SANDARE CYANMETHEMOGLOBIN REAGENT

Whole Blood Hemoglobin Determination

SANDARE CHEMICAL CO., INC.

The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Cyanmethemoglobin Reagent.

Pre-market Notification Details

Device IDK792503
510k NumberK792503
Device Name:SANDARE CYANMETHEMOGLOBIN REAGENT
ClassificationWhole Blood Hemoglobin Determination
Applicant SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHG  
CFR Regulation Number864.7500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-12-04
Decision Date1979-12-31

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