510(k) K915320 ยท DHR System, Test, Rheumatoid Factor
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
| Applicant | Trinity Laboratories, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Dec 7, 1992 |
| Received | Nov 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915320
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.