510(k) K160829

Device: Illumigene Mycoplasma Direct DNA Amplification Assay, Illumigene Mycoplasma Direct External Controls, Illumipro-10
Applicant: MERIDIAN BIOSCIENCE, INC.
510(k) number: K160829
Product code: OZX
Decision: Substantially Equivalent (SESE)
Decision date: 2016-06-13
Date received: 2016-03-25
Regulation: 866.3980
Classification name: Mycoplasma Pneumoniae Dna Assay System
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00840733102189	Alethia™ Mycoplasma Direct	MERIDIAN BIOSCIENCE, INC.	2019-01-08
00840733102103	Alethia™ Mycoplasma Direct External Control Kit	MERIDIAN BIOSCIENCE, INC.	2019-01-08
00840733101281	illumigene Mycoplasma Direct External Control Kit	MERIDIAN BIOSCIENCE, INC.	2016-09-23
00840733101274	illumigene Mycoplasma Direct	MERIDIAN BIOSCIENCE, INC.	2016-09-23

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K152800	illumigene Mycoplasma DNA Amplification Assay	Meridian Bioscience, Inc.	2015-10-23
K123423	ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT	Meridian Bioscience, Inc.	2013-06-05

summary

Decision Summary