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Re: samsamsamiam post# 156314

Saturday, 08/03/2019 2:58:40 PM

Saturday, August 03, 2019 2:58:40 PM

Post# of 205105
They haven't made public what "product line" or "test" they submitted to the FDA a year ago:

This is what we know from twitter:

3 Jul 2018
Arrayit provides 7/2/18 FDA update: (1) excellent meeting, (2) large attendance by FDA top brass, (3) insightful and instructive, (4) our entire clinical team wishes to thank the agency for their feedback and generosity, and (5) we believe that our test will receive FDA approval.

2 Jul 2018
Arrayit CLIA clinical team meets with top brass at the United States Food and Drug Administration FDA to discuss FDA approval of a major product line.

14 Mar 2018
Arrayit clinical team submits requested standard operating procedures SOPs and other documentation required for submission of a major microarray technology product to the United States Food and Drug Administration FDA for FDA regulatory clearance

26 Feb 2018
Arrayit clinical team assembles technical documents for a major microarray technology product line in preparation for 510(k) clearance submission with the United States Food and Drug Administration FDA

26 Jan 2018
Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance