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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 K912823
Device Name HIGH DENSITY LIPOPROTEIN CHOLESTEROL
Applicant
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Applicant Contact GARY J PROKSCH
Correspondent
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Correspondent Contact GARY J PROKSCH
Regulation Number862.1475
Classification Product Code
LBR  
Date Received06/26/1991
Decision Date 08/16/1991
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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