AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10— 510(k) K063347
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K063347 for AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10, Substantially Equivalent on 2007-03-20. 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.
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