The following data is part of a premarket notification filed by Siemens Helathcare Diagnostics Inc. with the FDA for Microscan Dried Gram-postive Mic/combo Panels.
| Device ID | K131275 |
| 510k Number | K131275 |
| Device Name: | MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | SIEMENS HELATHCARE DIAGNOSTICS INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Elisabeth Wariner |
| Correspondent | Elisabeth Wariner SIEMENS HELATHCARE 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 | 2013-05-03 |
| Decision Date | 2013-11-08 |
| Summary: | summary |