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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K933588
Device Name APHLELISA KIT
Applicant
Louisville Apl Diagnostics, Inc.
2311 Fallsview Rd.
P.O. Box 728
Louisville,  KY  40201
Applicant Contact E. NIGEL HARRIS
Correspondent
Louisville Apl Diagnostics, Inc.
2311 Fallsview Rd.
P.O. Box 728
Louisville,  KY  40201
Correspondent Contact E. NIGEL HARRIS
Regulation Number866.5660
Classification Product Code
MID  
Date Received07/26/1993
Decision Date 10/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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