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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K943027
Device Name CHOLESTEROL QVET
Applicant
PRISMA SYSTEMS
1721 BLACK RIVER BLVD.
ROME,  NY  13440
Applicant Contact LARRY BEASLEY
Correspondent
PRISMA SYSTEMS
1721 BLACK RIVER BLVD.
ROME,  NY  13440
Correspondent Contact LARRY BEASLEY
Regulation Number862.1175
Classification Product Code
CHH  
Date Received06/27/1994
Decision Date 01/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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