FDA 510(k) Application Details - K922953

Device Classification Name Cresol Red Colorimetry, Carbon-Dioxide

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510(K) Number K922953
Device Name Cresol Red Colorimetry, Carbon-Dioxide
Applicant EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN, NJ US
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Contact CAROL FAULKNER
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Regulation Number 862.1160

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Classification Product Code CIL
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Date Received 06/18/1992
Decision Date 09/09/1992
Decision SE - Substantially Equivalent
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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