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FDA 510(k), K041003, IMMUNOCARD TOXINS A & B, MODEL 712050
FDA 510(k), K041003, IMMUNOCARD TOXINS A & B, MODEL 712050
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510(K) Number: K041003
Device Name: IMMUNOCARD TOXINS A & B, MODEL 712050
Manufacturer: MERIDIAN BIOSCIENCE, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 04/19/2004
Decision Date: 08/20/2004
Regulation Medical Specialty: Microbiology
Device Name: IMMUNOCARD TOXINS A & B, MODEL 712050
Manufacturer: MERIDIAN BIOSCIENCE, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 04/19/2004
Decision Date: 08/20/2004
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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