510(k) K971614 ยท DHR System, Test, Rheumatoid Factor
QUANTA LITE RF IGM
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 20, 1997 |
| Received | May 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971614
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.