510(k) K060176 ยท MID System, Test, Anticardiolipin Immunological
EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
| Applicant | Theratest Laboratories, Inc., Lombard IL, US |
| Decision | Substantially Equivalent, Feb 7, 2006 |
| Received | Jan 23, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2006 | Thera Test Laboratories, Inc. EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.