510(k) K871196 ยท DHR System, Test, Rheumatoid Factor
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
| Applicant | Orion Diagnostica, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, May 6, 1987 |
| Received | Mar 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871196
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.