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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 K003752
Device Name BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
Applicant
Biosafe Laboratories, Inc.
100 Field Dr. #240
Lake Forest,  IL  60045
Applicant Contact JACK A MAGGIORE
Correspondent
Biosafe Laboratories, Inc.
100 Field Dr. #240
Lake Forest,  IL  60045
Correspondent Contact JACK A MAGGIORE
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JKA  
Date Received12/05/2000
Decision Date 03/23/2001
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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