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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 DRIVE #240
LAKE FOREST,  IL  60045
Applicant Contact LAURIE A WATERS
Correspondent
BIOSAFE LABORATORIES, INC.
100 FIELD DRIVE #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
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