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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K163015
Device Name Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
Applicant
BIO-RAD LABORATORIES
9500 JERONIMO ROAD
IRVINE,  CA  92618 -2017
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD LABORATORIES
9500 JERONIMO ROAD
IRVINE,  CA  92618 -2017
Correspondent Contact SUZANNE PARSONS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/28/2016
Decision Date 01/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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