The following data is part of a premarket notification filed by Globe Management Support, Inc. with the FDA for Crp-latex Seiken Xr Reagent System.
Device ID | K960702 |
510k Number | K960702 |
Device Name: | CRP-LATEX SEIKEN XR REAGENT SYSTEM |
Classification | C-reactive Protein, Antigen, Antiserum, And Control |
Applicant | GLOBE MANAGEMENT SUPPORT, INC. 12-1 NIHONBASHI, KABUTO-CHO Chuo-ku, Tokyo 103, JP |
Contact | Terrence T Lee |
Correspondent | Terrence T Lee GLOBE MANAGEMENT SUPPORT, INC. 12-1 NIHONBASHI, KABUTO-CHO Chuo-ku, Tokyo 103, JP |
Product Code | DCK |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-20 |
Decision Date | 1996-04-19 |
Summary: | summary |