510(k) K133002 ยท DHA System, Test, Human Chorionic Gonadotropin
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
| Applicant | Abbott Point of Care, Inc., Princton NJ, US |
| Decision | Substantially Equivalent, Apr 16, 2015 |
| Received | Sep 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133002
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.