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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Quality Control Material, Genetics, Dna
510(k) Number K063224
Device Name GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
Applicant
Gentris Corporation
133 Southcenter Ct.
Suite 400
Morrisville,  NC  27560
Applicant Contact DEBORAH N KLOOS
Correspondent
Gentris Corporation
133 Southcenter Ct.
Suite 400
Morrisville,  NC  27560
Correspondent Contact DEBORAH N KLOOS
Regulation Number866.5910
Classification Product Code
NZB  
Date Received10/24/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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