AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100— 510(k) K083222
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K083222 for AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100, Substantially Equivalent on 2009-07-31. 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.