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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 K902568
Device Name REFLOTRON HDL CHOLESTEROL TEST TABS
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Correspondent Contact JOHN D STEVENS
Regulation Number862.1475
Classification Product Code
LBR  
Date Received06/11/1990
Decision Date 08/09/1990
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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