FDA 510(k) Application Details - K980367

Device Classification Name Electrode, Ion-Specific, Chloride

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510(K) Number K980367
Device Name Electrode, Ion-Specific, Chloride
Applicant ABBOTT LABORATORIES
1920 HURD DRIVE
IRVING, TX 75038 US
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Contact ANDREW JOHNSON
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Regulation Number 862.1170

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Classification Product Code CGZ
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Date Received 01/29/1998
Decision Date 04/01/1998
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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