510(k) K032159 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
| Applicant | Access Bio Incorporate, North Brunswick NJ, US |
| Decision | Substantially Equivalent, Sep 5, 2003 |
| Received | Jul 15, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032159
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.