FDA 510(k) Application Details - K993083

Device Classification Name Electrode, Ion Specific, Potassium

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510(K) Number K993083
Device Name Electrode, Ion Specific, Potassium
Applicant ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING, TX 75038 US
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Contact MARK LITTLEFIELD
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Regulation Number 862.1600

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Classification Product Code CEM
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Date Received 09/15/1999
Decision Date 10/05/1999
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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