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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 K924694
Device Name LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC
Applicant
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1705
Classification Product Code
CDT  
Date Received09/16/1992
Decision Date 10/28/1992
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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