The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Chromid Mrsa Agar, Model: Ref 43 841.
| Device ID | K091024 |
| 510k Number | K091024 |
| Device Name: | CHROMID MRSA AGAR, MODEL: REF 43 841 |
| 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 | 2009-07-17 |
| Summary: | summary |