Cleared Traditional

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS

K122019 · Meridian Bioscience, Inc. · Microbiology
Sep 2012
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K122019 is an FDA 510(k) clearance for the STREPTOCOCCUS APP. SEROLOGICAL REAGENTS, a Group A Streptococcus Nucleic Acid Amplification Assay System (Class I — General Controls, product code OYZ), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 13, 2012, 65 days after receiving the submission on July 10, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K122019 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2012
Decision Date September 13, 2012
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OYZ — Group A Streptococcus Nucleic Acid Amplification Assay System
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740
Definition An In Vitro Diagnostic Test For The Detection Of Streptococcuc Pyogenes (group A Beta Hemolytic Streptococcus) In Throat Swab Specimens From Symptomatic Patients.