AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10— 510(k) K062467
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K062467 for AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10, Substantially Equivalent on 2006-11-22. Applicant: Axis-Shield Diagnostics, Ltd..
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Code CDD
- 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.