The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Septi-chek Columbia Broth Blood Culture.
| Device ID | K812730 |
| 510k Number | K812730 |
| Device Name: | SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE |
| Classification | Culture Media, Non-selective And Non-differential |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSG |
| CFR Regulation Number | 866.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-28 |
| Decision Date | 1981-10-23 |