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FDA 510(k), K080931, VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
FDA 510(k), K080931, VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
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510(K) Number: K080931
Device Name: VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
Manufacturer: BIOMERIEUX, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 04/02/2008
Decision Date: 06/11/2008
Regulation Medical Specialty: Microbiology
Device Name: VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
Manufacturer: BIOMERIEUX, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 04/02/2008
Decision Date: 06/11/2008
Regulation Medical Specialty: Microbiology
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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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