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 Levofloxacin (lvx) (0.008-16ug/ml).
| Device ID | K193358 |
| 510k Number | K193358 |
| Device Name: | MicroScan Dried Gram-Negative MIC/Combo Panels With Levofloxacin (Lvx) (0.008-16ug/mL) |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | Beckman Coulter, Inc. 1584 Enterprise Blvd West Sacramento, CA 95630 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan Beckman Coulter, Inc. 1584 Enterprise Blvd West Sacramento, CA 95630 |
| 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 | 2019-12-04 |
| Decision Date | 2020-03-03 |