The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Cobas-bio Centrifugal Analyzer.
| Device ID | K792671 |
| 510k Number | K792671 |
| Device Name: | COBAS-BIO CENTRIFUGAL ANALYZER |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-27 |
| Decision Date | 1980-01-17 |