FDA 510(k) Application Details - K993697

Device Classification Name Electrode, Ion-Specific, Chloride

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510(K) Number K993697
Device Name Electrode, Ion-Specific, Chloride
Applicant WALLAC OY
MUSTIONKATU 6
TURKU 20750 FI
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Contact GUNNEL LAAKSONEN
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Regulation Number 862.1170

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Classification Product Code CGZ
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Date Received 11/02/1999
Decision Date 06/09/2000
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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