The following data is part of a premarket notification filed by Siemens with the FDA for Microscan Dried Gram-positive Mic/combo Panels New Antimicrobial Test - Inducible Clindamycin.
| Device ID | K081182 |
| 510k Number | K081182 |
| Device Name: | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | SIEMENS 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Libby Warriner |
| Correspondent | Libby Warriner SIEMENS 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-25 |
| Decision Date | 2008-08-08 |
| Summary: | summary |