FDA 510(k) Application Details - K991146

Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone

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510(K) Number K991146
Device Name Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant BIOCHECK, INC.
9418 LASAINE AVE.
NORTHRIDGE, CA 91325 US
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Contact ROBIN J HELLEN
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Regulation Number 862.1690

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Classification Product Code JLW
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Date Received 04/05/1999
Decision Date 06/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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