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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, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K894057
Device Name QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
Applicant
PHOTEC DIAGNOSTICS, INC.
200 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact MC DONALD
Correspondent
PHOTEC DIAGNOSTICS, INC.
200 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact MC DONALD
Regulation Number862.1475
Classification Product Code
LBS  
Date Received06/07/1989
Decision Date 08/31/1989
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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