The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Microscan Dried Gram Positive Mic/combo Panels - Vancomycin (0.25-64 Ug/ml).
| Device ID | K152346 |
| 510k Number | K152346 |
| Device Name: | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 Ug/mL) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BECKMAN COULTER, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Shannon Popson |
| Correspondent | Shannon Popson 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2015-09-16 |
| Summary: | summary |