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FDA 510(k), K062368, WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
FDA 510(k), K062368, WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
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$149.00 USD
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510(K) Number: K062368
Device Name: WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
Manufacturer:
Device Classification Name: Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Regulation Number: 866.6030
Classification Product Code: OAU
Date Received: 08/14/2006
Decision Date: 01/31/2007
Regulation Medical Specialty: Immunology
Device Name: WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
Manufacturer:
Device Classification Name: Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Regulation Number: 866.6030
Classification Product Code: OAU
Date Received: 08/14/2006
Decision Date: 01/31/2007
Regulation Medical Specialty: Immunology
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