The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Rheuma-lex(tm) Syst: Rheumatoid Factor Latex Test.
| Device ID | K915320 |
| 510k Number | K915320 |
| Device Name: | RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh, NC 27613 |
| Contact | Bruce A Clinton |
| Correspondent | Bruce A Clinton TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 Raleigh, NC 27613 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-22 |
| Decision Date | 1992-12-07 |