510(k) K882895 ยท DHA System, Test, Human Chorionic Gonadotropin
MODIFIED BETA QUIK STAT EIA KIT
| Applicant | Pacific Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 12, 1988 |
| Received | Jul 11, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882895
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.