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FDA 510(k) Application Details - K070810
Device Classification Name
Fluorescence Polarization Immunoassay, Theophylline
More FDA Info for this Device
510(K) Number
K070810
Device Name
Fluorescence Polarization Immunoassay, Theophylline
Applicant
BIOKIT S.A.
CAN MALE S/N
LLISSA D'AMUNT
BARCELONA 08186 ES
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Contact
JOAN GUIXER
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Regulation Number
862.3880
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Classification Product Code
LGS
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More FDA Info for this Product Code
Date Received
03/26/2007
Decision Date
06/08/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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