510(k) K024195 ยท MID System, Test, Anticardiolipin Immunological
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Jan 3, 2003 |
| Received | Dec 20, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024195
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.