The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Chromid Vre Agar, Model: Ref 43 851.
| Device ID | K091025 |
| 510k Number | K091025 |
| Device Name: | CHROMID VRE AGAR, MODEL: REF 43 851 |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nancy Weaver |
| Correspondent | Nancy Weaver BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-10 |
| Decision Date | 2010-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026313128 | K091025 | 000 |