AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

Assay, Glycosylated Hemoglobin

AXIS-SHIELD DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Axsym Hba1c Reagents, Axsym Hba1c Calibrators, Axsym Hba1c Controls.

Pre-market Notification Details

Device IDK072686
510k NumberK072686
Device Name:AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
ClassificationAssay, Glycosylated Hemoglobin
Applicant AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland,  GB Dd2 1xa
ContactClaire Dora
CorrespondentClaire Dora
AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland,  GB Dd2 1xa
Product CodeLCP  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-24
Decision Date2008-03-17
Summary:summary

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