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FDA 510(k) Application Details - K052301
Device Classification Name
Radioimmunoassay, Thyroid-Stimulating Hormone
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510(K) Number
K052301
Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD, CA 92011 US
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Contact
DOROTHY PETERSON
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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
08/22/2005
Decision Date
01/04/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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