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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 K871301
Device Name ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
Applicant
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Applicant Contact LUANN OCHS
Correspondent
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Correspondent Contact LUANN OCHS
Regulation Number862.1705
Classification Product Code
CDT  
Date Received04/01/1987
Decision Date 04/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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