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FDA 510(k), K993553, GTI-FVIII INHIBITOR ASSAY
FDA 510(k), K993553, GTI-FVIII INHIBITOR ASSAY
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510(K) Number: K993553
Device Name: GTI-FVIII INHIBITOR ASSAY
Manufacturer: GENETIC TESTING INSTITUTE
Device Classification Name: test, qualitative and quantitative factor deficiency
Regulation Number: 864.7290
Classification Product Code: GGP
Date Received: 10/20/1999
Decision Date: 02/01/2000
Regulation Medical Specialty: Hematology
Device Name: GTI-FVIII INHIBITOR ASSAY
Manufacturer: GENETIC TESTING INSTITUTE
Device Classification Name: test, qualitative and quantitative factor deficiency
Regulation Number: 864.7290
Classification Product Code: GGP
Date Received: 10/20/1999
Decision Date: 02/01/2000
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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