510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160829Substantially Equivalent

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

Meridian Bioscience Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160829 is the FDA 510(k) clearance record for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10, a class II device, cleared for Meridian Bioscience, Inc. on under FDA product code OZX (Mycoplasma Pneumoniae Dna Assay System). FDA's definition for product code OZX reads: "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...". FDA records list 38 510(k) clearances for Meridian Bioscience, Inc., from to . As of , FDA records show no recalls naming K160829.

Clearance record

Decision date
Received
(80 days to decision)
Product code
OZX Mycoplasma Pneumoniae Dna Assay System
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Meridian Bioscience, Inc. 3471 River Hills Dr., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZX

Trailing 12 months

FDA records hold no clearances under product code OZX in the trailing twelve months.

FDA records show no clearances under product code OZX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OZX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260