FDA 510(k), K193053, Tina-quant Hemoglobin A1cDx Gen.3
FDA 510(k), K193053, Tina-quant Hemoglobin A1cDx Gen.3
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$149.00 USD
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510(K) Number: K193053
Device Name: Tina-quant Hemoglobin A1cDx Gen.3
Manufacturer:
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 11/01/2019
Decision Date: 03/26/2020
Regulation Medical Specialty: Clinical Chemistry
Device Name: Tina-quant Hemoglobin A1cDx Gen.3
Manufacturer:
Device Classification Name: Hemoglobin A1c Test System
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 11/01/2019
Decision Date: 03/26/2020
Regulation Medical Specialty: Clinical Chemistry