The following data is part of a premarket notification filed by Globe Management Support, Inc. with the FDA for Rf-latex Seiken Reagent System.
Device ID | K960703 |
510k Number | K960703 |
Device Name: | RF-LATEX SEIKEN REAGENT SYSTEM |
Classification | System, Test, Rheumatoid Factor |
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 | DHR |
CFR Regulation Number | 866.5775 [🔎] |
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 |