Introl CF Panel I Control, Model: G106

FDA 510(k) K083171 · Maine Molecular Quality Controls, Inc.

Substantially Equivalent

510(k) numberK083171

Submission

Device name
Introl CF Panel I Control, Model: G106
Applicant
Maine Molecular Quality Controls, Inc.
Scarborough, ME, US
Received
October 27, 2008
Decision date
December 16, 2008
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.

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Questions and answers

When was Introl CF Panel I Control, Model: G106 cleared by the FDA?

Introl CF Panel I Control, Model: G106 (K083171) received a 510(k) decision of Substantially Equivalent on December 16, 2008, 50 days after the submission was received.

What is the product code of K083171?

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