510(k) K933588 ยท MID System, Test, Anticardiolipin Immunological
APHLELISA KIT
| Applicant | Louisville Apl Diagnostics, Inc., Louisville KY, US |
| Decision | Substantially Equivalent, Oct 13, 1994 |
| Received | Jul 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2007 | Louisville Apl Diagnostics Inc APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856). Terminated |
MID | None listed |
| Aug 17, 2007 | Louisville Apl Diagnostics Inc APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (addres Terminated |
MID | None listed |
| Aug 17, 2007 | Louisville Apl Diagnostics Inc APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc.-- (current ad Terminated |
MID | None listed |
| Aug 17, 2007 | Louisville Apl Diagnostics Inc APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current a Terminated |
MID | None listed |
| Jul 24, 2007 | Louisville Apl Diagnostics Inc american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77 Terminated |
MID | None listed |
| Jul 24, 2007 | Louisville Apl Diagnostics Inc american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77 Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.