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 | K061536 |
510k Number | K061536 |
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 |
Subsequent Product Code | LRG |
Subsequent Product Code | LTT |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-02 |
Decision Date | 2006-07-18 |
Summary: | summary |