510(k) K031048 ยท JHI Visual, Pregnancy Hcg, Prescription Use
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
| Applicant | Access Bio Incorporate, North Brunswick NJ, US |
| Decision | Substantially Equivalent, Jun 16, 2003 |
| Received | Apr 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031048
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.