HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812

Ph Rate Measurement, Carbon-dioxide

HICHEM DIAGNOSTICS

The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Co2 Acid Reagent Kit,product Number 88812.

Pre-market Notification Details

Device IDK925552
510k NumberK925552
Device Name:HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
ClassificationPh Rate Measurement, Carbon-dioxide
Applicant HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea,  CA  92621
ContactWynn Stocking
CorrespondentWynn Stocking
HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea,  CA  92621
Product CodeJFL  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-03
Decision Date1993-02-12

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