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 Meropenem/vaborbactam (0.03/8-64/8ug/ml).
| Device ID | K183127 |
| 510k Number | K183127 |
| Device Name: | MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem/Vaborbactam (0.03/8-64/8ug/mL) |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691 |
| Contact | Elaine Marie Duncan |
| Correspondent | Elaine Marie Duncan 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 | 2018-11-13 |
| Decision Date | 2019-02-12 |
| Summary: | summary |