510(k) K891188 ยท CFQ Radioimmunoassay, Immunoglobulins (G, A, M)
TITAN GEL IFE TRIVALENT ANTISERUM
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Mar 22, 1989 |
| Received | Mar 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891188
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.