ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

Urinary Homocystine (nonquantitative) Test System

AXIS-SHIELD DIAGNOSTICS, LTD.

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

Pre-market Notification Details

Device IDK073640
510k NumberK073640
Device Name:ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
ClassificationUrinary Homocystine (nonquantitative) Test System
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 CodeLPS  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1377 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-04-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.