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FDA 510(k), K082898, AMEDICA DRUG SCREEN TEST CUP
FDA 510(k), K082898, AMEDICA DRUG SCREEN TEST CUP
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510(K) Number: K082898
Device Name: AMEDICA DRUG SCREEN TEST CUP
Manufacturer: AMEDICA BIOTECH, INC.
Device Classification Name: test, opiates, over the counter
Regulation Number: 862.3650
Classification Product Code: NGL
Date Received: 09/30/2008
Decision Date: 12/19/2008
Regulation Medical Specialty: Toxicology
Device Name: AMEDICA DRUG SCREEN TEST CUP
Manufacturer: AMEDICA BIOTECH, INC.
Device Classification Name: test, opiates, over the counter
Regulation Number: 862.3650
Classification Product Code: NGL
Date Received: 09/30/2008
Decision Date: 12/19/2008
Regulation Medical Specialty: Toxicology
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- 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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