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510(k) K162274

Solana Strep Complete Assay by Quidel Corporation — Product Code PGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2016
Date Received
August 12, 2016
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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