510(k) K973464 ยท DHR System, Test, Rheumatoid Factor
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Oct 22, 1997 |
| Received | Sep 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973464
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.