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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 K903733
Device Name ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
Applicant
Institute For Clinical Applications
126 Brookline Ave.
Boston,  MA  02215
Applicant Contact TENLEY E ALBRIGHT
Correspondent
Institute For Clinical Applications
126 Brookline Ave.
Boston,  MA  02215
Correspondent Contact TENLEY E ALBRIGHT
Regulation Number862.1475
Classification Product Code
LBR  
Date Received08/16/1990
Decision Date 01/15/1991
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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