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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Hdl
510(k) Number K944975
Device Name MAGNETIC HDL CHOLESTEROL TEST
Applicant
Reference Diagnostics, Inc.
23 Crosby Dr.
Bedford,  MA  01730
Applicant Contact JOSEPH LAWLOR
Correspondent
Reference Diagnostics, Inc.
23 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact JOSEPH LAWLOR
Regulation Number862.1475
Classification Product Code
LBR  
Date Received10/11/1994
Decision Date 08/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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