510(k) K984173 ยท MID System, Test, Anticardiolipin Immunological
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 22, 1998 |
| Received | Nov 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2003 | Zeus Scientific Inc Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO. Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.