SANDARE GLYCOHEMOGLOBIN PROCEDURE

Assay, Glycosylated Hemoglobin

SANDARE CHEMICAL CO., INC.

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

Pre-market Notification Details

Device IDK802832
510k NumberK802832
Device Name:SANDARE GLYCOHEMOGLOBIN PROCEDURE
ClassificationAssay, Glycosylated Hemoglobin
Applicant SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-12
Decision Date1981-01-16

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