REAGENT KIT, BAKERS DIAGNOSTIC

Alkaline Picrate, Colorimetry, Creatinine

J.T. BAKER CHEMICAL CO.

The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Reagent Kit, Bakers Diagnostic.

Pre-market Notification Details

Device IDK790044
510k NumberK790044
Device Name:REAGENT KIT, BAKERS DIAGNOSTIC
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant J.T. BAKER CHEMICAL CO. 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 Received1979-01-05
Decision Date1979-02-22

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