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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 K990993
Device Name BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
Applicant
Biocheck, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Applicant Contact ROBIN HELLEN
Correspondent
Biocheck, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Correspondent Contact ROBIN HELLEN
Regulation Number862.1690
Classification Product Code
JLW  
Date Received03/24/1999
Decision Date 06/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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