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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 K970393
Device Name THYROID STIMULATING HORMONE METHOD
Applicant
Dade Chemistry Systems, Inc.
Rt. 896, Glascow Bldg. 500
Glasgow,  DE  19702
Applicant Contact REBECCA S AYASH
Correspondent
Dade Chemistry Systems, Inc.
Rt. 896, Glascow Bldg. 500
Glasgow,  DE  19702
Correspondent Contact REBECCA S AYASH
Regulation Number862.1690
Classification Product Code
JLW  
Date Received02/03/1997
Decision Date 03/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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