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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K162772
Device Name ARIES GBS Assay
Applicant
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN,  TX  78727
Applicant Contact CHRISTIE HUGHES
Correspondent
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN,  TX  78727
Correspondent Contact CHRISTIE HUGHES
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received10/03/2016
Decision Date 12/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02497430
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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