FDA 510(k) Application Details - K961657

Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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510(K) Number K961657
Device Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant CIBA CORNING DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD, MA 02052-1688 US
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Contact William J Pignato
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Regulation Number 862.1120

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Classification Product Code CHL
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Date Received 04/30/1996
Decision Date 06/25/1996
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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