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510(k) K141338

LIAT STREP A ASSAY by Iquum, Inc. — Product Code PGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2014
Date Received
May 21, 2014
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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