IMMUNOCARD TOXINS A & B, MODEL 712050
FDA 510(k) clearance K041003 · decided 2004-08-20
Clearance details
- K-number
- K041003
- Device name
- IMMUNOCARD TOXINS A & B, MODEL 712050
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-19
- Decision date
- 2004-08-20
- Days to decision
- 123 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 |
|---|---|---|
| ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium d recall (Z-1203-06) | Meridian Bioscience Inc | 2006-07-04 |