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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 K984102
Device Name ACL/APS FACS KIT
Applicant
Louisville Apl Diagnostics, Inc.
3988 Flowers Rd., Suite 620
Doraville,  GA  30360
Applicant Contact SILVIA S PIERANGELI
Correspondent
Louisville Apl Diagnostics, Inc.
3988 Flowers Rd., Suite 620
Doraville,  GA  30360
Correspondent Contact SILVIA S PIERANGELI
Regulation Number866.5660
Classification Product Code
MID  
Date Received11/17/1998
Decision Date 03/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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