510(k) K833148 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ENZYME ANA TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 21, 1983 |
| Received | Sep 15, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2009 | Immuno Concepts Inc ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufacture Terminated |
DHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.