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FDA 510(k), K090413, A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
FDA 510(k), K090413, A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
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$149.00 USD
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510(K) Number: K090413
Device Name: A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
Manufacturer:
Device Classification Name: Assay, Glycosylated Hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 02/18/2009
Decision Date: 05/14/2009
Regulation Medical Specialty: Hematology
Device Name: A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
Manufacturer:
Device Classification Name: Assay, Glycosylated Hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 02/18/2009
Decision Date: 05/14/2009
Regulation Medical Specialty: Hematology
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