The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Chromid Strepto B Agar.
| Device ID | K163042 |
| 510k Number | K163042 |
| Device Name: | ChromID Strepto B Agar |
| Classification | Gbs Culture Media, Selective And Differential |
| Applicant | bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Contact | Karen Russell |
| Correspondent | Karen Russell bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Product Code | PQZ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2017-01-27 |
| Summary: | summary |