ETEST SUBMISSION FOR IMIPENEM
FDA 510(k) clearance K960989 · decided 1996-05-20
Clearance details
- K-number
- K960989
- Device name
- ETEST SUBMISSION FOR IMIPENEM
- Applicant
- Ab Biodisk
- Decision
- Substantially Equivalent
- Date received
- 1996-03-11
- Decision date
- 1996-05-20
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JWY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 recall (Z-0825-2023) | Biomerieux Inc | 2023-01-04 |
| ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a q recall (Z-1529-2017) | BioMerieux SA | 2017-03-21 |