510(k) K981021 ยท MID System, Test, Anticardiolipin Immunological
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jun 2, 1998 |
| Received | Mar 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981021
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2004 | Zeus Scientific Inc Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, subst Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.