CHROMID CARBA agar (CARB)
FDA 510(k) clearance K181092 · decided 2018-07-06
Clearance details
- K-number
- K181092
- Device name
- CHROMID CARBA agar (CARB)
- Applicant
- Biomerieux S.A.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-25
- Decision date
- 2018-07-06
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- JSO
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Marcy-L'Etoile, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012 recall (Z-0839-2023) | Biomerieux Inc | 2023-01-04 |