510(k) K072264 ยท JHI Visual, Pregnancy Hcg, Prescription Use
FASTPACK HCG IMMUNOASSAY
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 6, 2007 |
| Received | Aug 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072264
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.