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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 K932373
Device Name HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
Applicant
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact CHARLES A WILLAND
Correspondent
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact CHARLES A WILLAND
Regulation Number866.5660
Classification Product Code
MID  
Date Received05/17/1993
Decision Date 07/16/1993
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
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