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 |