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FDA 510(k), K103227, ORATECT ORAL FLUID DRUG SCREEN DEVICES
FDA 510(k), K103227, ORATECT ORAL FLUID DRUG SCREEN DEVICES
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510(K) Number: K103227
Device Name: ORATECT ORAL FLUID DRUG SCREEN DEVICES
Manufacturer: BRANAN MEDICAL CORPORATION
Device Classification Name: enzyme immunoassay, cocaine and cocaine metabolites
Regulation Number: 862.3250
Classification Product Code: DIO
Date Received: 11/01/2010
Decision Date: 04/11/2012
Regulation Medical Specialty: Toxicology
Device Name: ORATECT ORAL FLUID DRUG SCREEN DEVICES
Manufacturer: BRANAN MEDICAL CORPORATION
Device Classification Name: enzyme immunoassay, cocaine and cocaine metabolites
Regulation Number: 862.3250
Classification Product Code: DIO
Date Received: 11/01/2010
Decision Date: 04/11/2012
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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