K091025 is an FDA 510(k) clearance for the CHROMID VRE AGAR, MODEL: REF 43 851. This device is classified as a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II - Special Controls, product code JSO).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 2, 2010, 326 days after receiving the submission on April 10, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1700.
| 510(k) Number | K091025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2009 |
| Decision Date | March 02, 2010 |
| Days to Decision | 326 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1700 |