PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT

Assay, Glycosylated Hemoglobin

MEDISENSE, INC.

The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision A1c Home Hba1c Sample Collection Kit.

Pre-market Notification Details

Device IDK983253
510k NumberK983253
Device Name:PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
ClassificationAssay, Glycosylated Hemoglobin
Applicant MEDISENSE, INC. 4-A CROSBY DR. Bedford,  MA  01730 -1402
ContactDenise Haley
CorrespondentDenise Haley
MEDISENSE, INC. 4-A CROSBY DR. Bedford,  MA  01730 -1402
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-16
Decision Date1998-11-20
Summary:summary

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