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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 K963213
Device Name BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Correspondent Contact JOHN D STEVENS
Regulation Number862.1475
Classification Product Code
LBS  
Date Received08/16/1996
Decision Date 10/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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