The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Synergies Plus Gram-positive Mic/combo Panel With Synercid (0.12-2ug/ml 5dilution Breakpoint Sequence.
| Device ID | K063366 |
| 510k Number | K063366 |
| Device Name: | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Robert Eusebio |
| Correspondent | Robert Eusebio DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LON |
| Subsequent Product Code | JWY |
| Subsequent Product Code | LRG |
| Subsequent Product Code | LTT |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-07 |
| Decision Date | 2006-12-08 |
| Summary: | summary |