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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 K942998
Device Name TRIGLYCERODES QVET
Applicant
PRISMA SYSTEMS
1721 BLACK RIVER BLVD.
SUITE 200
ROME,  NY  13440
Applicant Contact LARRY J BEASLEY
Correspondent
PRISMA SYSTEMS
1721 BLACK RIVER BLVD.
SUITE 200
ROME,  NY  13440
Correspondent Contact LARRY J BEASLEY
Regulation Number862.1705
Classification Product Code
CDT  
Date Received06/23/1994
Decision Date 11/22/1994
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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