ROCHE CONTROL SERUM P

Multi-analyte Controls, All Kinds (assayed)

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Control Serum P.

Pre-market Notification Details

Device IDK954656
510k NumberK954656
Device Name:ROCHE CONTROL SERUM P
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactRita Smith
CorrespondentRita Smith
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-10
Decision Date1995-12-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.