The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas(r) Core Ft4 Eia.
Device ID | K932607 |
510k Number | K932607 |
Device Name: | COBAS(R) CORE FT4 EIA |
Classification | Radioimmunoassay, Free Thyroxine |
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 | CEC |
CFR Regulation Number | 862.1695 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-28 |
Decision Date | 1994-01-24 |