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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
510(k) Number K873049
Device Name TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact CHERI EMMONS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact CHERI EMMONS
Regulation Number862.1705
Classification Product Code
CDT  
Date Received08/04/1987
Decision Date 08/28/1987
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
Recalls CDRH Recalls
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