510(k) K921968 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
| Applicant | Tech-Co, Inc., Placentia CA, US |
| Decision | Substantially Equivalent, Jun 28, 1996 |
| Received | Apr 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921968
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.