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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
Original Applicant
BIO-RAD
4000 alfred nobel dr.
hercules,  CA  94547 -1803
Original 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
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