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FDA 510(k) Application Details - K972330
Device Classification Name
Fluorescence Polarization Immunoassay, Phenobarbital
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510(K) Number
K972330
Device Name
Fluorescence Polarization Immunoassay, Phenobarbital
Applicant
OXIS INTL., INC.
6040 NORTH CUTTER CIR., #317
PORTLAND, OR 97217-3935 US
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Contact
LYNDA M TAYLOR
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Regulation Number
862.3660
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Classification Product Code
LGQ
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More FDA Info for this Product Code
Date Received
06/23/1997
Decision Date
07/14/1997
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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