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FDA 510(k) Application Details - K001154
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K001154
Device Name
Electrode, Ion Specific, Sodium
Applicant
I-STAT CORP.
104 WINDSOR CENTER DR.
EAST WINDSOR, NJ 08520 US
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Contact
PAUL VANDERWERF
Other 510(k) Applications for this Contact
Regulation Number
862.1665
More FDA Info for this Regulation Number
Classification Product Code
JGS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2000
Decision Date
04/18/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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