The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Control Serum P.
Device ID | K954656 |
510k Number | K954656 |
Device Name: | ROCHE CONTROL SERUM P |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Contact | Rita Smith |
Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-10 |
Decision Date | 1995-12-21 |