The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Septi-check Blood Culture Slide.
| Device ID | K812731 |
| 510k Number | K812731 |
| Device Name: | SEPTI-CHECK BLOOD CULTURE SLIDE |
| Classification | Culture Media, Selective And Differential |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-28 |
| Decision Date | 1981-10-19 |