510(k) K820647 ยท LIM Test, Screening, For D Positive Fetal Rbc'S
GAMMA FETAL BLEED SCREENING TEST
| Applicant | Gamma Biologicals, Inc., Walker MI, US |
| Decision | Substantially Equivalent, May 12, 1982 |
| Received | Mar 9, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820647
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.