510(k) K853539 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 25, 1985 |
| Received | Aug 23, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853539
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.