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FDA 510(k) Application Details - K020148
Device Classification Name
Electrode, Ion-Specific, Chloride
More FDA Info for this Device
510(K) Number
K020148
Device Name
Electrode, Ion-Specific, Chloride
Applicant
PHOENIX DIAGNOSTICS, INC.
8 TECH CIRCLE
NATICK, MA 01760 US
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Contact
RAM NUNNA
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Regulation Number
862.1170
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Classification Product Code
CGZ
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More FDA Info for this Product Code
Date Received
01/16/2002
Decision Date
02/04/2002
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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