ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

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 Architect Hba1c, Architect Hba1c, And Architect Hba1c.

Pre-market Notification Details

Device IDK121842
510k NumberK121842
Device Name:ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
ClassificationAssay, Glycosylated Hemoglobin
Applicant AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland,  GB Dd2 1xa
ContactClaire I Dora
CorrespondentClaire I Dora
AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland,  GB Dd2 1xa
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-25
Decision Date2012-12-12
Summary:summary

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