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FDA 510(k), K053175, AMEDITECH DRUGSMARTCUP
FDA 510(k), K053175, AMEDITECH DRUGSMARTCUP
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510(K) Number: K053175
Device Name: AMEDITECH DRUGSMARTCUP
Manufacturer: AMEDITECH, INC.
Device Classification Name: enzyme immunoassay, amphetamine
Regulation Number: 862.3100
Classification Product Code: DKZ
Date Received: 11/14/2005
Decision Date: 12/08/2005
Regulation Medical Specialty: Toxicology
Device Name: AMEDITECH DRUGSMARTCUP
Manufacturer: AMEDITECH, INC.
Device Classification Name: enzyme immunoassay, amphetamine
Regulation Number: 862.3100
Classification Product Code: DKZ
Date Received: 11/14/2005
Decision Date: 12/08/2005
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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