The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Synergies Plus Gram-positive Mic/combo Panels.
| Device ID | K071076 |
| 510k Number | K071076 |
| Device Name: | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
| 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 | 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 | 2007-04-16 |
| Decision Date | 2007-05-21 |
| Summary: | summary |