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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 K974733
Device Name BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact EDWARD R KIMMELMAN
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact EDWARD R KIMMELMAN
Regulation Number862.1475
Classification Product Code
LBR  
Date Received12/18/1997
Decision Date 01/26/1998
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
Recalls CDRH Recalls
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