510(k) K984135 ยท GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, May 26, 1999 |
| Received | Nov 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984135
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.