Company ยท US
Louisville Apl Diagnostics Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2002. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 9 |
Latest 510(k) clearances
Latest recalls
| 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 | K933588 |
| 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 | K933588 |
| 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 | K933588 |
| 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 | K933588 |
| 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 | K933588 |
| 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 | K933588 |