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EX-99.1 - TearLab Corpex99-1.htm






Washington, DC 20549







Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934


Date of Report (Date of earliest event reported)


October 10, 2018





(Exact name of registrant as specified in its charter)


Delaware   000-51030   59-343-4771

(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)


150 La Terraza Blvd., Ste 101

Escondido, CA 92025

(Address of principal executive offices, including zip code)


(858) 455-6006

(Registrant’s telephone number, including area code)


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 (see General Instruction A.2. below):


[  ] 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))


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).


Emerging growth company [  ]


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]






Item 8.01. Other Events


On October 10, 2018, TearLab Corporation (the “Company”) issued a press release announcing the U.S. Food and Drug Administration (“FDA”) has determined that the TearLab DiscoveryTM MMP-9 test, has not met the criteria for substantial equivalence based upon data and information submitted by TearLab in its 510(k) submission. A copy of this press release is attached thereto as Exhibit 99.1 and is hereby incorporated by reference herein.


Item 9.01. Financial Statements and Exhibits.


(d) Exhibits.


Exhibit No.   Description
99.1   Press Release, dated October 10, 2018






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.


  By: /s/ Michael Marquez
    Michael Marquez
    Interim Chief Financial Officer


Date: October 10, 2018