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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K943028
Device Name HDL 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 Number862.1475
Classification Product Code
LBS  
Date Received06/27/1994
Decision Date 12/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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