The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Cobas-blo Reagents (lactate Dehydro.
| Device ID | K792658 |
| 510k Number | K792658 |
| Device Name: | COBAS-BLO REAGENTS (LACTATE DEHYDRO |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | HOFFMANN-LA ROCHE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-26 |
| Decision Date | 1980-01-17 |