510(k) K955449 ยท MID System, Test, Anticardiolipin Immunological
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
| Applicant | American Laboratory Products Co., Ltd., Windham NH, US |
| Decision | Substantially Equivalent, May 23, 1996 |
| Received | Nov 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955449
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.