BAKER DIAG. ULTRARATE CHLORIDE KIT

Coulometric, Chloride

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 Baker Diag. Ultrarate Chloride Kit.

Pre-market Notification Details

Device IDK802080
510k NumberK802080
Device Name:BAKER DIAG. ULTRARATE CHLORIDE KIT
ClassificationCoulometric, Chloride
Applicant J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJFS  
CFR Regulation Number862.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-08-28
Decision Date1980-10-10

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