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FDA 510(k), K151986, ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
FDA 510(k), K151986, ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
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$149.00 USD
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510(K) Number: K151986
Device Name: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Device Classification Name: radioimmunoassay, testosterones and dihydrotestosterone
Regulation Number: 862.1680
Classification Product Code: CDZ
Date Received: 07/17/2015
Decision Date: 06/29/2016
Regulation Medical Specialty: Clinical Chemistry
Device Name: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Device Classification Name: radioimmunoassay, testosterones and dihydrotestosterone
Regulation Number: 862.1680
Classification Product Code: CDZ
Date Received: 07/17/2015
Decision Date: 06/29/2016
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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