The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Core Prolactin Eia.
Device ID | K930305 |
510k Number | K930305 |
Device Name: | COBAS CORE PROLACTIN EIA |
Classification | Radioimmunoassay, Prolactin (lactogen) |
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 | CFT |
CFR Regulation Number | 862.1625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-21 |
Decision Date | 1993-08-19 |