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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
510(k) Number K897169
Device Name QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
Applicant
Photec Diagnostics, Inc.
200 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact BARRY MCDONALD
Correspondent
Photec Diagnostics, Inc.
200 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact BARRY MCDONALD
Regulation Number862.1705
Classification Product Code
CDT  
Date Received12/28/1989
Decision Date 02/23/1990
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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