The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Reagent For Bun.
Device ID | K954000 |
510k Number | K954000 |
Device Name: | ROCHE REAGENT FOR BUN |
Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Contact | Maria Feijoo |
Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Product Code | CDQ |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-25 |
Decision Date | 1995-10-25 |