510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063224Substantially Equivalent

Gentrisure Human Genomic DNA Reference Control

Gentris Corporation, Morrisville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K063224 is the FDA 510(k) clearance record for GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL, a class II device, cleared for Gentris Corporation on under FDA product code NZB (Quality Control Material, Genetics, Dna). FDA's definition for product code NZB reads: "Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical...". FDA records list one 510(k) clearance for Gentris Corporation. As of , FDA records show no recalls naming K063224.

Clearance record

Decision date
Received
(59 days to decision)
Product code
NZB Quality Control Material, Genetics, Dna
Regulation
21 CFR 866.5910
Device class
Class II
Review panel
Microbiology
Applicant
Gentris Corporation 133 Southcenter Ct., Morrisville NC
510(k) summary
Statement
Third party review
No

Clearances, product code NZB

Trailing 12 months

FDA records hold no clearances under product code NZB in the trailing twelve months.

FDA records show no clearances under product code NZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260