LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT

Assay, Glycosylated Hemoglobin

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Glyco-hemoglobin Diag. Test Kit.

Pre-market Notification Details

Device IDK801289
510k NumberK801289
Device Name:LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT
ClassificationAssay, Glycosylated Hemoglobin
Applicant LEECO DIAGNOSTICS, 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 Received1980-05-30
Decision Date1980-06-30

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