FDA 510(k) Application Details - K991870

Device Classification Name Electrode, Ion-Specific, Chloride

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510(K) Number K991870
Device Name Electrode, Ion-Specific, Chloride
Applicant A.P. TOTAL CARE, INC.
70 HAWLEY AVE,
PO BOX 6216
BRIDGEPORT, CT US
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Contact LUIS P LEON
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Regulation Number 862.1170

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Classification Product Code CGZ
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Date Received 06/01/1999
Decision Date 07/30/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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