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FDA 510(k) Application Details - K981243
Device Classification Name
Radioimmunoassay, Free Thyroxine
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510(K) Number
K981243
Device Name
Radioimmunoassay, Free Thyroxine
Applicant
BIOSTRIDE DIAGNOSTICS, INC.
1206 SESAME DR.
SUNNYVALE, CA 94087 US
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Contact
JANIS FREESTONE
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Regulation Number
862.1695
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Classification Product Code
CEC
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More FDA Info for this Product Code
Date Received
04/06/1998
Decision Date
06/29/1998
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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