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FDA 510(k) Application Details - K060543
Device Classification Name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
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510(K) Number
K060543
Device Name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant
CLINICAL MICRO SENSORS, INC.
757 SOUTH RAYMOND AVE.
PASADENA, CA 91105 US
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Contact
WILLIAM COTY
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Regulation Number
866.5900
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Classification Product Code
NUA
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More FDA Info for this Product Code
Date Received
03/01/2006
Decision Date
03/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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