The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Microscan Dried Gram Positive Mic/combo Panels With Vancomycin (0.25-64 Mcg/ml).
| Device ID | K150039 |
| 510k Number | K150039 |
| Device Name: | MicroScan Dried Gram Positive MIC/Combo Panels With Vancomycin (0.25-64 Mcg/mL) |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | Siemens Healthcare Diagnostics Inc. 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Contact | Shanon Popson |
| Correspondent | Shanon Popson Siemens Healthcare Diagnostics 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 | 2015-01-09 |
| Decision Date | 2015-07-02 |
| Summary: | summary |