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 With Ertapenem (0.002-32 Mcg/ml.
| Device ID | K032706 |
| 510k Number | K032706 |
| Device Name: | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML |
| Classification | Manual Antimicrobial Susceptibility Test 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 | 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 | 2003-09-02 |
| Decision Date | 2004-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590704063 | K032706 | 000 |
| 15099590657949 | K032706 | 000 |
| 15099590657895 | K032706 | 000 |