The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Chromid Mrsa.
| Device ID | K151688 |
| 510k Number | K151688 |
| Device Name: | ChromID MRSA |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Jewell Coulson |
| Correspondent | Jewell Coulson 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 | 2015-06-23 |
| Decision Date | 2016-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026420758 | K151688 | 000 |