CREATININE TEST

Alkaline Picrate, Colorimetry, Creatinine

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Creatinine Test.

Pre-market Notification Details

Device IDK811664
510k NumberK811664
Device Name:CREATININE TEST
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant KING DIAGNOSTICS, INC. 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 Received1981-06-15
Decision Date1981-06-25

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