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FDA 510(k), K974881, TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
FDA 510(k), K974881, TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
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510(K) Number: K974881
Device Name: TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
Manufacturer: BIOSITE INCORPORATED
Device Classification Name: antigen, c. difficile
Regulation Number: 866.2660
Classification Product Code: MCB
Date Received: 12/30/1997
Decision Date: 03/20/1998
Regulation Medical Specialty: Microbiology
Device Name: TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
Manufacturer: BIOSITE INCORPORATED
Device Classification Name: antigen, c. difficile
Regulation Number: 866.2660
Classification Product Code: MCB
Date Received: 12/30/1997
Decision Date: 03/20/1998
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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