revogene

FDA 510(k) K170558 · Genepoc, Inc.

Substantially Equivalent

510(k) numberK170558

Submission

Device name
revogene
Applicant
Genepoc, Inc.
Quebec, CA
Received
February 24, 2017
Decision date
May 25, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OOI – Real Time Nucleic Acid Amplification System
Device class
Class II (moderate risk)
Regulation
21 CFR 862.2570
Specialty
Clinical Chemistry

The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated…

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K123955Quantstudio DX Real-Time PCR InstrumentOOI · Traditional Life Technologies Corporation03/08/2013SE
K113319Rotor-Gene Q MDXOOI · Traditional QIAGEN GmbH02/06/2012SE

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Questions and answers

When was revogene cleared by the FDA?

revogene (K170558) received a 510(k) decision of Substantially Equivalent on May 25, 2017, 90 days after the submission was received.

What is the product code of K170558?

The FDA product code is OOI – Real Time Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 862.2570.