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.. Device class: 2.
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Code LPS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
Recent devices under product code LPS
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- K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT
- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K113793 — HOMOCYSTEINE TEST
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
More clearances from Axis-Shield Diagnostics, Ltd.
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