Hemosil F11 & FV DNA Control

Q: What is the product code of K093737?

The FDA product code is NZB – Quality Control Material, Genetics, Dna, a Class II (moderate risk) device regulated under 21 CFR 866.5910.

FDA 510(k) K093737 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK093737

Submission

Device name: Hemosil F11 & FV DNA Control
Applicant: Instrumentation Laboratory CO
Bedford, MA, US
Received: December 4, 2009
Decision date: May 4, 2010
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NZB – Quality Control Material, Genetics, Dna
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5910
Specialty: Microbiology

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 instrument variation. This type of device includes synthetic dna controls and cell-line based controls.

Other 510(k)s with product code NZB

510(k)	Device	Applicant	Decision
K083171	Introl CF Panel I Control, Model: G106NZB · Traditional	Maine Molecular Quality Controls, Inc.	12/16/2008SE
K063224	Gentrisure Human Genomic DNA Reference ControlNZB · Traditional	Gentris Corporation	12/22/2006SE

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Questions and answers

When was Hemosil F11 & FV DNA Control cleared by the FDA?

Hemosil F11 & FV DNA Control (K093737) received a 510(k) decision of Substantially Equivalent on May 4, 2010, 151 days after the submission was received.

What is the product code of K093737?

The FDA product code is NZB – Quality Control Material, Genetics, Dna, a Class II (moderate risk) device regulated under 21 CFR 866.5910.