GLYCATED HEMOGLOBIN CONTROLS

Assay, Glycosylated Hemoglobin

PRIMUS CORP.

The following data is part of a premarket notification filed by Primus Corp. with the FDA for Glycated Hemoglobin Controls.

Pre-market Notification Details

Device IDK940143
510k NumberK940143
Device Name:GLYCATED HEMOGLOBIN CONTROLS
ClassificationAssay, Glycosylated Hemoglobin
Applicant PRIMUS CORP. P.O. BOX 22599 Kansas City,  MO  64114
ContactRick Harrison
CorrespondentRick Harrison
PRIMUS CORP. P.O. BOX 22599 Kansas City,  MO  64114
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-11
Decision Date1994-03-15

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