510(k) K952283 ยท DHA System, Test, Human Chorionic Gonadotropin
AMERLITE HCG-60 ASSAY
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jul 17, 1995 |
| Received | May 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952283
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.