The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Chromid Carba Agar (carb).
| Device ID | K181092 |
| 510k Number | K181092 |
| Device Name: | CHROMID CARBA Agar (CARB) |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile, FR 69280 |
| Contact | Asa Karlsson |
| Correspondent | Asa Karlsson bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile, FR 69280 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-25 |
| Decision Date | 2018-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026409913 | K181092 | 000 |