510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122019Substantially Equivalent

Streptococcus App. Serological Reagents

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

K122019 is the FDA 510(k) clearance record for STREPTOCOCCUS APP. SEROLOGICAL REAGENTS, a class I device, cleared for Meridian Bioscience, Inc. on under FDA product code OYZ (Group A Streptococcus Nucleic Acid Amplification Assay System). FDA's definition for product code OYZ reads: "An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients". FDA records list 38 510(k) clearances for Meridian Bioscience, Inc., from to . As of , FDA records show no recalls naming K122019.

Clearance record

Decision date
Received
(65 days to decision)
Product code
OYZ Group A Streptococcus Nucleic Acid Amplification Assay System
Regulation
21 CFR 866.3740
Device class
Class I
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 OYZ

Trailing 12 months

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

FDA records show no clearances under product code OYZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYZ, 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