UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
April 18, 2011
Date of report (Date of earliest event reported)
BECKMAN COULTER, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-10109 | 95-104-0600 | ||
(State of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
250 S. Kraemer Blvd.
Brea, California 92821
(Address of principal executive offices) (Zip Code)
(714) 993-5321
(Registrants telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events.
As Beckman Coulter, Inc. (the Company) has previously disclosed, the Company is currently conducting a prospective clinical trial to establish the diagnostic performance of its troponin test on its DxI instruments and Access instruments using patient samples from the intended use population. Based on the progress of the Companys clinical trial, its ongoing compliance and quality system improvement initiative, and its discussions with the U.S. Food and Drug Administration ( FDA), the Company expects to delay its submission of two separate 510(k) notices to FDA for the troponin test until the third quarter of 2011, one for Access instruments and another for DxI instruments. However, there can be no assurances that such 510(k) notices will be submitted in such time frame or that, upon submission, the updated 510(k) clearances will be received in a timely manner from FDA, if at all.
Forward-Looking Statements
This Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements contain words such as expect, estimate, could, will, likely, possible, may or the negative thereof or comparable terminology, and may include information regarding the Companys expectations, goals or intentions regarding the future.
Forward-looking statements included herein are based on managements current expectations, estimates, forecasts and projections about the Company and are subject to risks and uncertainties, some of which may be beyond the Companys control that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include our ability to identify and locate qualified test sites, our ability to recruit patients meeting the necessary criteria, our ability to obtain necessary trial results and actions required in connection with our ongoing compliance and quality system improvement initiative. Additional factors that could cause actual results to differ are discussed in the Companys Form 10-K for the fiscal year ended December 31, 2010 as well as in reports the Company files with the Securities and Exchange Commission from time to time. Forward-looking statements contained herein are made only as of the date hereof, and we undertake no obligation to update these disclosures except as required by law.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: April 18, 2011 | BECKMAN COULTER, INC. | |||||
By: | /s/ Daniel B. Kim | |||||
Name: | Daniel B. Kim | |||||
Title: | Assistant General Counsel and Assistant Secretary |