510(k) K041946 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 16, 2004 |
| Received | Jul 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041946
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.