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 Eravacycline (erv) (0.016-32 Ug/ml).
| Device ID | K190109 |
| 510k Number | K190109 |
| Device Name: | MicroScan Dried Gram Negative MIC/Combo Panels With Eravacycline (ERV) (0.016-32 Ug/mL) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691 |
| Product Code | JWY |
| Subsequent Product Code | LRG |
| Subsequent Product Code | LTT |
| Subsequent Product Code | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-23 |
| Decision Date | 2019-04-18 |