• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K141410, ORAGENE DX OGD-500.001, by DNA Genotek, Inc.

FDA 510(k) K141410, ORAGENE DX OGD-500.001, by DNA Genotek, Inc.

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510(K) Number: K141410
Device Name: ORAGENE DX OGD-500.001
Manufacturer: DNA Genotek, Inc.
Device Classification Name: dna specimen collection, saliva
Regulation Number: 862.1675
Classification Product Code: OYJ
Date Received: 05/29/2014
Decision Date: 02/19/2015
Regulation Medical Specialty: Clinical Chemistry
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