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FDA 510(k), K171771, ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
FDA 510(k), K171771, ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
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510(K) Number: K171771
Device Name: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Manufacturer: Siemens Healthcare Diagnostics Inc.
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 06/14/2017
Decision Date: 12/04/2017
Regulation Medical Specialty: Clinical Chemistry
Device Name: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Manufacturer: Siemens Healthcare Diagnostics Inc.
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 06/14/2017
Decision Date: 12/04/2017
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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