FDA 510(k), K182651, HbA1c Advanced
FDA 510(k), K182651, HbA1c Advanced
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$149.00 USD
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$149.00 USD
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510(K) Number: K182651
Device Name: HbA1c Advanced
Manufacturer:
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 09/24/2018
Decision Date: 01/16/2019
Regulation Medical Specialty: Clinical Chemistry
Device Name: HbA1c Advanced
Manufacturer:
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 09/24/2018
Decision Date: 01/16/2019
Regulation Medical Specialty: Clinical Chemistry