illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

FDA 510(k) K160829 · Meridian Bioscience, Inc.

Substantially Equivalent

510(k) numberK160829

Submission

Device name
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
Applicant
Meridian Bioscience, Inc.
Cincinnati, OH, US
Received
March 25, 2016
Decision date
June 13, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OZX – Mycoplasma Pneumoniae Dna Assay System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3980
Specialty
Microbiology

A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

Other 510(k)s with product code OZX

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K152800illumigene Mycoplasma DNA Amplification AssayOZX · Special Meridian Bioscience, Inc.10/23/2015SE
K123423Illumigene Mycoplasama DNA Amplification Assay, and Illumigene Mycoplasma External…OZX · Traditional Meridian Bioscience, Inc.06/05/2013SE

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Questions and answers

When was illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 cleared by the FDA?

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 (K160829) received a 510(k) decision of Substantially Equivalent on June 13, 2016, 80 days after the submission was received.

What is the product code of K160829?

The FDA product code is OZX – Mycoplasma Pneumoniae Dna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.