The following data is part of a premarket notification filed by Dade Microscan, Inc. with the FDA for Microscan Dried Gram-positive Mic/combo Panels - Ertapenem.
| Device ID | K043589 |
| 510k Number | K043589 |
| Device Name: | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Cynthia Van Duker |
| Correspondent | Cynthia Van Duker DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| 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 | 2004-12-28 |
| Decision Date | 2005-02-14 |
| Summary: | summary |