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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 K963424
Device Name OLYMPUS LIPASE REAGENT
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1705
Classification Product Code
CDT  
Date Received08/30/1996
Decision Date 01/14/1997
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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