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FDA 510(k), K984361, ORAL-EZE ORAL FLUID COLLECTION SYSTEM
FDA 510(k), K984361, ORAL-EZE ORAL FLUID COLLECTION SYSTEM
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510(K) Number: K984361
Device Name: ORAL-EZE ORAL FLUID COLLECTION SYSTEM
Manufacturer: OSBORN LABORATORIES, INC.
Device Classification Name: oral fluid drugs of abuse and alcohol test specimen collection device
Regulation Number: 862.1675
Classification Product Code: PJD
Date Received: 12/07/1998
Decision Date: 01/13/1999
Regulation Medical Specialty: Clinical Chemistry
Device Name: ORAL-EZE ORAL FLUID COLLECTION SYSTEM
Manufacturer: OSBORN LABORATORIES, INC.
Device Classification Name: oral fluid drugs of abuse and alcohol test specimen collection device
Regulation Number: 862.1675
Classification Product Code: PJD
Date Received: 12/07/1998
Decision Date: 01/13/1999
Regulation Medical Specialty: Clinical Chemistry
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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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