Imdx Flu A/B and RSV for Abbott M2000

FDA 510(k) K131584 · Intelligent Medical Devices, Inc.

Substantially Equivalent

510(k) numberK131584

Submission

Device name
Imdx Flu A/B and RSV for Abbott M2000
Applicant
Intelligent Medical Devices, Inc.
Beverly, MA, US
Received
May 31, 2013
Decision date
August 21, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OCC – Respiratory Virus Panel Nucleic Acid Assay System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3980
Specialty
Microbiology

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…

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K140198Imdx HSV-1/2 for Abbott M2000OQO · Traditional 05/13/2014SE
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Questions and answers

When was Imdx Flu A/B and RSV for Abbott M2000 cleared by the FDA?

Imdx Flu A/B and RSV for Abbott M2000 (K131584) received a 510(k) decision of Substantially Equivalent on August 21, 2013, 82 days after the submission was received.

What is the product code of K131584?

The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.