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FDA 510(k) Application Details - K980819
Device Classification Name
Radioimmunoassay, Free Thyroxine
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510(K) Number
K980819
Device Name
Radioimmunoassay, Free Thyroxine
Applicant
BIOCIRCUITS CORP.
1324 CHESAPEAKE TERR.
SUNNYVALE, CA 94089 US
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Contact
SHEILA J RAMERMAN
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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
03/03/1998
Decision Date
04/03/1998
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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