510(k) K961351 ยท DHA System, Test, Human Chorionic Gonadotropin
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 3, 1996 |
| Received | Apr 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961351
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.