510(k) K961815 ยท LKJ Antinuclear Antibody, Antigen, Control
QUALITROL ANA CONTROL SERUM SET
| Applicant | Consolidated Technologies, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 27, 1996 |
| Received | May 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961815
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.