URINE CHLORIDE

Mercuric Thiocyanate, Colorimetry, Chloride

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Urine Chloride.

Pre-market Notification Details

Device IDK923036
510k NumberK923036
Device Name:URINE CHLORIDE
ClassificationMercuric Thiocyanate, Colorimetry, Chloride
Applicant HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactRobert L Habig
CorrespondentRobert L Habig
HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeCHJ  
CFR Regulation Number862.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-19
Decision Date1992-09-09

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