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FDA 510(k), K041951, XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
FDA 510(k), K041951, XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
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510(K) Number: K041951
Device Name: XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
Manufacturer: REMEL INC
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 07/20/2004
Decision Date: 11/15/2004
Regulation Medical Specialty: Microbiology
Device Name: XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
Manufacturer: REMEL INC
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 07/20/2004
Decision Date: 11/15/2004
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
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