510(k) K842216 ยท GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
CULTURESET HSV ISOLATION & ID SYS
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Jan 29, 1985 |
| Received | Jun 4, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842216
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.