The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Microscan Dried Gram-negative Mic/combo Panel, B1017 Panel Series.
| Device ID | K101425 |
| 510k Number | K101425 |
| Device Name: | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Contact | Elisabeth Warriner |
| Correspondent | Elisabeth Warriner SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Product Code | LRG |
| Subsequent Product Code | JWY |
| Subsequent Product Code | LTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-20 |
| Decision Date | 2010-09-10 |
| Summary: | summary |