AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
FDA 510(k) clearance K063347 · decided 2007-03-20
Clearance details
- K-number
- K063347
- Device name
- AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-06
- Decision date
- 2007-03-20
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- NHX
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.