The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Ready Renal Profile Reagent Strip.
| Device ID | K904049 |
| 510k Number | K904049 |
| Device Name: | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP |
| Classification | O-phthalaldehyde, Urea Nitrogen |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Contact | Carol Krieger |
| Correspondent | Carol Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Product Code | JGZ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-04 |
| Decision Date | 1990-10-12 |