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FDA 510(k), K082205, FACTOR VIII ANTIBODY SCREEN
FDA 510(k), K082205, FACTOR VIII ANTIBODY SCREEN
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510(K) Number: K082205
Device Name: FACTOR VIII ANTIBODY SCREEN
Manufacturer: GENETIC TESTING INSTITUTE
Device Classification Name: test, qualitative and quantitative factor deficiency
Regulation Number: 864.7290
Classification Product Code: GGP
Date Received: 08/05/2008
Decision Date: 11/20/2008
Regulation Medical Specialty: Hematology
Device Name: FACTOR VIII ANTIBODY SCREEN
Manufacturer: GENETIC TESTING INSTITUTE
Device Classification Name: test, qualitative and quantitative factor deficiency
Regulation Number: 864.7290
Classification Product Code: GGP
Date Received: 08/05/2008
Decision Date: 11/20/2008
Regulation Medical Specialty: Hematology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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