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510(k) K925553

HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 by Hichem Diagnostics — Product Code JFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
November 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Rate Measurement, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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