510(k) K812002 ยท GGK Products, Red-Cell Lysing Products
ELUAID
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Oct 28, 1981 |
| Received | Jul 14, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812002
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.