PREMIER C. DIFFICILE, MODIFICATION
FDA 510(k) clearance K926442 · decided 1993-01-27
Clearance details
- K-number
- K926442
- Device name
- PREMIER C. DIFFICILE, MODIFICATION
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-16
- Decision date
- 1993-01-27
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- LLH
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per recall (Z-0463-03) | Meridian Bioscience Inc | 2003-01-23 |