510(k) K980314 ยท LIM Test, Screening, For D Positive Fetal Rbc'S
FETAL D TECTION KIT
| Applicant | Biopool Intl., Inc., West Chester PA, US |
| Decision | Substantially Equivalent, Apr 8, 1998 |
| Received | Jan 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980314
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.