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FDA 510(k) Application Details - K990993
Device Classification Name
Radioimmunoassay, Thyroid-Stimulating Hormone
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510(K) Number
K990993
Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant
BIOCHECK, INC.
9418 LASAINE AVE.
NORTHRIDGE, CA 91325 US
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Contact
ROBIN HELLEN
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Regulation Number
862.1690
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Classification Product Code
JLW
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More FDA Info for this Product Code
Date Received
03/24/1999
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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