DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA— 510(k) K023285
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K023285 for DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA, Substantially Equivalent on 2002-10-09. 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
Recent devices under product code NHX
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- K112810 — MULTI-ANALYTE DETECTION SYSTEMS
- K110296 — AXIS-SHIELD ANTI-CCP
More clearances from Axis-Shield Diagnostics, Ltd.
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