CREATININE TEST

Alkaline Picrate, Colorimetry, Creatinine

SCLAVO, INC.

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

Pre-market Notification Details

Device IDK843179
510k NumberK843179
Device Name:CREATININE TEST
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant SCLAVO, 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 Received1984-08-13
Decision Date1984-09-07

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