NG-Test® CTX-M MULTI
FDA 510(k) clearance K243499 · decided 2025-06-04
Clearance details
- K-number
- K243499
- Device name
- NG-Test® CTX-M MULTI
- Applicant
- Ng Biotech
- Decision
- Substantially Equivalent
- Date received
- 2024-11-12
- Decision date
- 2025-06-04
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- PTJ
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Guipry, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NG-Test CARBA 5 (K191889) | Ng Biotech | 2019-10-02 |
| RAPIDEC CARBA NP (K162385) | Biomerieux S.A. | 2017-04-27 |
Recalls involving this device
No recalls on record reference this clearance.