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FDA 510(k) Application Details - K062503
Device Classification Name
Radioimmunoassay, Cholyglycine, Bile Acids
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510(K) Number
K062503
Device Name
Radioimmunoassay, Cholyglycine, Bile Acids
Applicant
CATACHEM, INC.
955 CONNECTICUT AVENUE
SUITE 4106
BRIDGEPORT, CT 06607 US
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Contact
LUIS P LEON
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Regulation Number
862.1177
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Classification Product Code
KWW
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More FDA Info for this Product Code
Date Received
08/25/2006
Decision Date
01/19/2007
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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