The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Etest Ceftolozane/ Tazobactam (0.016-256 Ug/ml).
| Device ID | K170670 |
| 510k Number | K170670 |
| Device Name: | Etest Ceftolozane/ Tazobactam (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 | 2017-03-06 |
| Decision Date | 2017-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026418748 | K170670 | 000 |
| 03573026618681 | K170670 | 000 |