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 |