ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k) clearance K070262 · decided 2007-03-14
Clearance details
- K-number
- K070262
- Device name
- ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- Applicant
- Oxoid , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-26
- Decision date
- 2007-03-14
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Basingstoke, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in car recall (Z-0795-2014) | Remel Inc | 2014-01-21 |