ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
FDA 510(k) clearance K121044 · decided 2012-05-01
Clearance details
- K-number
- K121044
- Device name
- ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-06
- Decision date
- 2012-05-01
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- NJR
- Device class
- 1
- Regulation number
- 866.3740
- 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 |
|---|---|---|
| Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplificat recall (Z-0569-2026) | Meridian Bioscience Inc | 2025-11-19 |