ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35— 510(k) K083868
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K083868 for ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35, Substantially Equivalent on 2009-09-25. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Code NHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
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More clearances from Axis-Shield Diagnostics, Ltd.
view allRecalls naming K083868
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083868.
Data sourced from openFDA. This site is unofficial and independent of the FDA.