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FDA 510(k), K130255, HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
FDA 510(k), K130255, HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
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510(K) Number: K130255
Device Name: HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
Manufacturer: ABBOTT LABORATORIES
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 02/01/2013
Decision Date: 02/28/2014
Regulation Medical Specialty: Clinical Chemistry
Device Name: HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
Manufacturer: ABBOTT LABORATORIES
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 02/01/2013
Decision Date: 02/28/2014
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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