510(k) K070921 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
| Applicant | Applied Dna Technologies, Inc., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Jun 29, 2007 |
| Received | Apr 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070921
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.