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FDA 510(k) Application Details - K213486
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K213486
Device Name
Electrode, Ion Specific, Sodium
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park, IL 60064 US
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Contact
Michele Smith Waheed
Other 510(k) Applications for this Contact
Regulation Number
862.1665
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Classification Product Code
JGS
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More FDA Info for this Product Code
Date Received
10/29/2021
Decision Date
03/10/2022
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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