510(k) K971379 ยท DHR System, Test, Rheumatoid Factor
TINAQUANT RHEUMATOID FACTOR ASSAY
| Applicant | Boehringer Mannheim Corp., Concord CA, US |
| Decision | Substantially Equivalent, Jun 17, 1997 |
| Received | Apr 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971379
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.