510(k) K852360 ยท GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
ORTHO DNA PROBE HSV CONFIRMATION TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Sep 12, 1985 |
| Received | Jun 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852360
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.