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FDA 510(k)

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

K-Number: K063224 · 2006-12-22

ApplicantGentris Corporation
Decision Date2006-12-22
Product CodeNZB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Gentris Corporation. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K063224. The device is classified under product code NZB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL?

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Gentris Corporation. The 510(k) number is K063224.

When did GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL receive FDA 510(k) clearance?

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL received FDA 510(k) clearance on 2006-12-22, under 510(k) number K063224.

Who is the listed applicant for GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL?

The FDA 510(k) record lists Gentris Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL?

The FDA product code for GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL is NZB.

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Related Devices (Code: NZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093737HEMOSIL F11 & FV DNA CONTROLInstrumentation Laboratory COK083171INTROL CF PANEL I CONTROL, MODEL: G106Maine Molecular Quality Controls, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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