510(k) K900617 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
SERATEST ENA [SSA] KIT
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Feb 23, 1990 |
| Received | Feb 8, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900617
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.