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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 K011525
Device Name SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
Applicant
Biosafe Laboratories, Inc.
100 Field Dr. #240
Lake Forest,  IL  60045
Applicant Contact LAURIE A WATERS
Correspondent
Biosafe Laboratories, Inc.
100 Field Dr. #240
Lake Forest,  IL  60045
Correspondent Contact LAURIE A WATERS
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JKA  
Date Received05/17/2001
Decision Date 07/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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