KINETIC CREATININE

Alkaline Picrate, Colorimetry, Creatinine

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Kinetic Creatinine.

Pre-market Notification Details

Device IDK830447
510k NumberK830447
Device Name:KINETIC CREATININE
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-10
Decision Date1983-03-24

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