ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS— 510(k) K073640
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K073640 for ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS, Substantially Equivalent on 2008-04-24. Applicant: Axis-Shield Diagnostics, Ltd..
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Code LPS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.