GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL— 510(k) K063224

Name: FDA 510(k) clearance K063224
Creator: U.S. Food and Drug Administration
Published: 2006-12-22

Substantially Equivalent

Gentris Corporation

FDA 510(k) clearance K063224 for GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL, Substantially Equivalent on 2006-12-22. Applicant: Gentris Corporation. Device class: 2.

Clearance details

Applicant: Gentris Corporation
Product code: Code NZB
Device class: Class 2
Regulation: 21 CFR 866.5910
Advisory panel: Microbiology
Date received: 2006-10-24
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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