510(k) K896271 ยท DHR System, Test, Rheumatoid Factor
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
| Applicant | Biokit USA, Inc., Barcelona, ES |
| Decision | Substantially Equivalent, Nov 8, 1989 |
| Received | Oct 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896271
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.