The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Microscan Dried Gram -negative Mic/combo Panels With Tigecycline (0.015- 32 Mcg/ml).
| Device ID | K083262 |
| 510k Number | K083262 |
| Device Name: | MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Libby Warriner |
| Correspondent | Libby Warriner SIEMENS HEALTHCARE DIAGNOSTICS 2040 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 | 2008-11-05 |
| Decision Date | 2009-02-18 |
| Summary: | summary |