510(k) K855221 ยท DHR System, Test, Rheumatoid Factor
SERATEST RF (HEMAGGLUTINATION) KIT
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 22, 1986 |
| Received | Dec 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855221
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.