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FDA 510(k), K152061, IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
FDA 510(k), K152061, IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
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510(K) Number: K152061
Device Name: IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Device Classification Name: system, test, thyroid autoantibody
Regulation Number: 866.5870
Classification Product Code: JZO
Date Received: 07/24/2015
Decision Date: 03/03/2016
Regulation Medical Specialty: Immunology
Device Name: IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Device Classification Name: system, test, thyroid autoantibody
Regulation Number: 866.5870
Classification Product Code: JZO
Date Received: 07/24/2015
Decision Date: 03/03/2016
Regulation Medical Specialty: Immunology
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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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