510(k) K021103 ยท LKJ Antinuclear Antibody, Antigen, Control
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 24, 2002 |
| Received | Apr 5, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021103
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.