510(k) K970894 ยท DHA System, Test, Human Chorionic Gonadotropin
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 14, 1997 |
| Received | Mar 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970894
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.