The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Microscan Dried Gram Negative Mic/combo Panels With Ceftazidime/avibactam (0.25/4 - 64/4 Ug/ml).
| Device ID | K172337 |
| 510k Number | K172337 |
| Device Name: | MicroScan Dried Gram Negative MIC/Combo Panels With Ceftazidime/Avibactam (0.25/4 - 64/4 Ug/mL) |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691 |
| Contact | Teresa S. Wong |
| Correspondent | Teresa S. Wong Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691 |
| Product Code | LTT |
| Subsequent Product Code | JWY |
| Subsequent Product Code | LRG |
| Subsequent Product Code | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-02 |
| Decision Date | 2017-12-15 |
| Summary: | summary |