Atlas FDA

APHLELISA KIT

FDA 510(k) clearance K933588 · decided 1994-10-13

Clearance details

K-number
K933588
Device name
APHLELISA KIT
Applicant
Louisville Apl Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1993-07-26
Decision date
1994-10-13
Days to decision
444 days
Clearance type
Traditional
Product code
MID
Device class
2
Regulation number
866.5660
Medical specialty
Immunology
Advisory committee
Immunology
Location
Louisville, KY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by L recall (Z-0034-2008)Louisville Apl Diagnostics Inc2007-10-04
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnos recall (Z-1175-2007)Louisville Apl Diagnostics Inc2007-08-17
APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, recall (Z-1176-2007)Louisville Apl Diagnostics Inc2007-08-17
APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, recall (Z-1177-2007)Louisville Apl Diagnostics Inc2007-08-17
american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. recall (Z-1103-2007)Louisville Apl Diagnostics Inc2007-07-24
american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. recall (Z-1104-2007)Louisville Apl Diagnostics Inc2007-07-24