The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Reagent For Creatinine.
Device ID | K941837 |
510k Number | K941837 |
Device Name: | ROCHE REAGENT FOR CREATININE |
Classification | Alkaline Picrate, Colorimetry, Creatinine |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Contact | Carol L Krieger |
Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Product Code | CGX |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-13 |
Decision Date | 1994-08-26 |