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510(k) K172402

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit by Luminex Corporation — Product Code PGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2017
Date Received
August 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Device Class
Class II
Regulation Number
866.2680
Review Panel
MI
Submission Type

An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

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Other clearances for product code PGX

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