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 Ciprofloxacin-s (0.004 – 8 µg/ml).
| Device ID | K172912 |
| 510k Number | K172912 |
| Device Name: | MicroScan Dried Gram-Negative MIC/Combo Panels With Ciprofloxacin-S (0.004 – 8 µg/mL) |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | Beckman Coulter Inc. 2040 Enterprise Bldv West Sacramento, CA 95691 |
| Contact | Shannon Popson |
| Correspondent | Shannon Popson Beckman Coulter Inc. 2040 Enterprise Bldv 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 | 2017-09-25 |
| Decision Date | 2017-12-07 |
| Summary: | summary |