Last synced on 14 November 2025 at 11:06 pm

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

Page Type
Cleared 510(K)
510(k) Number
K073640
510(k) Type
Traditional
Applicant
Axis-Shield Diagnostics, Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
4/24/2008
Days to Decision
120 days
Submission Type
Summary

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

Page Type
Cleared 510(K)
510(k) Number
K073640
510(k) Type
Traditional
Applicant
Axis-Shield Diagnostics, Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
4/24/2008
Days to Decision
120 days
Submission Type
Summary