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FDA 510(k), K120009, TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
FDA 510(k), K120009, TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
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510(K) Number: K120009
Device Name: TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
Manufacturer: ABBOTT LABORATORIES
Device Classification Name: radioimmunoassay, testosterones and dihydrotestosterone
Regulation Number: 862.1680
Classification Product Code: CDZ
Date Received: 01/03/2012
Decision Date: 09/11/2012
Regulation Medical Specialty: Clinical Chemistry
Device Name: TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
Manufacturer: ABBOTT LABORATORIES
Device Classification Name: radioimmunoassay, testosterones and dihydrotestosterone
Regulation Number: 862.1680
Classification Product Code: CDZ
Date Received: 01/03/2012
Decision Date: 09/11/2012
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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