FDA 510(k), K183048, Quantisal II Oral Fluid Collection Device

FDA 510(k), K183048, Quantisal II Oral Fluid Collection Device

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510(K) Number: K183048
Device Name: Quantisal II Oral Fluid Collection Device
Manufacturer: Immunalysis Corporation
Device Classification Name: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Regulation Number: 862.1675
Classification Product Code: PJD
Date Received: 11/02/2018
Decision Date: 07/29/2019
Regulation Medical Specialty: Clinical Chemistry

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