510(k) K952490 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM
| Applicant | Roche Image Analysis Systems, Elon College NC, US |
| Decision | Substantially Equivalent, Dec 15, 1995 |
| Received | May 30, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952490
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.