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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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