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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 K854152
Device Name TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
Applicant
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact LEAONARD A DWARICA
Correspondent
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact LEAONARD A DWARICA
Regulation Number862.1705
Classification Product Code
CDT  
Date Received10/11/1985
Decision Date 11/05/1985
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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