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FDA 510(k), K935296, CLOSTRIDIUM DIFFICILE TOX-B TEST
FDA 510(k), K935296, CLOSTRIDIUM DIFFICILE TOX-B TEST
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510(K) Number: K935296
Device Name: CLOSTRIDIUM DIFFICILE TOX-B TEST
Manufacturer: TECHLAB, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 11/03/1993
Decision Date: 04/26/1994
Regulation Medical Specialty: Microbiology
Device Name: CLOSTRIDIUM DIFFICILE TOX-B TEST
Manufacturer: TECHLAB, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 11/03/1993
Decision Date: 04/26/1994
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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