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.
| Device ID | K061687 |
| 510k Number | K061687 |
| Device Name: | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Maureen Mende |
| Correspondent | Maureen Mende DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590699413 | K061687 | 000 |