The following data is part of a premarket notification filed by Biomerieux, Inc with the FDA for Etest Ceftazidime/avibactam (cza) (0.016 - 256 Ug/ml).
| Device ID | K172150 |
| 510k Number | K172150 |
| Device Name: | Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 Ug/mL) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Cherece L. Jones |
| Correspondent | Cherece L. Jones bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-17 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026494537 | K172150 | 000 |
| 03573026619657 | K172150 | 000 |