510(k) K031052 ยท DHA System, Test, Human Chorionic Gonadotropin
CARESTART HCG ONE-STEP PREGNANCY TEST
| Applicant | Access Bio Incorporate, North Brunswick NJ, US |
| Decision | Substantially Equivalent, Jun 13, 2003 |
| Received | Apr 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031052
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.