510(k) K032868 ยท MID System, Test, Anticardiolipin Immunological
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Oct 14, 2003 |
| Received | Sep 15, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032868
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2010 | Bio-Rad Laboratories Inc BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic. Terminated |
DHC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.