510(k) K962469 ยท MID System, Test, Anticardiolipin Immunological
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
| Applicant | American Laboratory Products Co., Ltd., Windham NH, US |
| Decision | Substantially Equivalent, Sep 9, 1996 |
| Received | Jun 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962469
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.