CHLORIDE REAGENT KIT

Coulometric, Chloride

A-KEM, INC.

The following data is part of a premarket notification filed by A-kem, Inc. with the FDA for Chloride Reagent Kit.

Pre-market Notification Details

Device IDK873127
510k NumberK873127
Device Name:CHLORIDE REAGENT KIT
ClassificationCoulometric, Chloride
Applicant A-KEM, INC. P.O. BOX 1589 82 INDUSTRIAL EAST Clifton,  NJ  07015
ContactSteven Lee
CorrespondentSteven Lee
A-KEM, INC. P.O. BOX 1589 82 INDUSTRIAL EAST Clifton,  NJ  07015
Product CodeJFS  
CFR Regulation Number862.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-10
Decision Date1987-10-23

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