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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K170232
Device Name AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
Applicant
Boditech Med, Inc.
43, Geodudanji 1-Gil, Dongnae-Myeon
Chuncheon-Si,  KR
Applicant Contact HYUNG-JU OH
Correspondent
Boditech Med, Inc.
43, Geodudanji 1-Gil, Dongnae-Myeon
Chuncheon-Si,  KR
Correspondent Contact HYUNG-JU OH
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
KHO  
Date Received01/25/2017
Decision Date 10/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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