510(k) K901596 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
NOVA LITE(TM) ANA KSL
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 2, 1990 |
| Received | Apr 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2011 | Inova Diagnostics Incorporated Inova Diagnostic Inc., NOVA Lite ANA KSL Kit
Part Number: 708390. in vitro diagnostic. Terminated |
DHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.