The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Microscan Dried Gram-positive Mic/combo Panels, Model B1017.
| Device ID | K091264 |
| 510k Number | K091264 |
| Device Name: | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Contact | Shannon Popson |
| Correspondent | Shannon Popson SIEMENS HEALTHCARE DIAGNOSTICS 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 | 2009-04-30 |
| Decision Date | 2009-07-22 |
| Summary: | summary |