510(k) K012567 ยท MID System, Test, Anticardiolipin Immunological
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Aug 23, 2001 |
| Received | Aug 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012567
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.