The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Dried Gram-negative Mic/combo Panels (gemifloxacin).
| Device ID | K033948 |
| 510k Number | K033948 |
| Device Name: | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Cynthia Van Duker |
| Correspondent | Cynthia Van Duker DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LRG |
| Subsequent Product Code | JWY |
| 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 | 2003-12-19 |
| Decision Date | 2004-03-01 |
| Summary: | summary |