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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 K903311
Device Name NOVAPATH TSH ENZYME IMMUNOASSAY
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Applicant Contact TREVOR WALL
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Correspondent Contact TREVOR WALL
Regulation Number862.1690
Classification Product Code
JLW  
Date Received07/24/1990
Decision Date 09/07/1990
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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