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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, Low Density, Lipoprotein
510(k) Number K893740
Device Name LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
Applicant
Reference Diagnostics, Inc.
P.O. Box 109
Arlington,  MA  02174
Applicant Contact LAWLOR, PHD.
Correspondent
Reference Diagnostics, Inc.
P.O. Box 109
Arlington,  MA  02174
Correspondent Contact LAWLOR, PHD.
Regulation Number862.1475
Classification Product Code
MRR  
Date Received05/17/1989
Decision Date 03/19/1990
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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