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FDA 510(k) Application Details - K040750
Device Classification Name
Electrode, Ion Specific, Potassium
More FDA Info for this Device
510(K) Number
K040750
Device Name
Electrode, Ion Specific, Potassium
Applicant
CLINICAL ANALYSIS CORPORATION, INC.
2100 QUAKER POINTE DRIVE
QUAKERTOWN, PA 18951-2182 US
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Contact
CHARLES MCBRAIRTY
Other 510(k) Applications for this Contact
Regulation Number
862.1600
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Classification Product Code
CEM
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More FDA Info for this Product Code
Date Received
03/23/2004
Decision Date
10/28/2004
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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