ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01— 510(k) K061165
Substantially EquivalentSweden Diagnostics (Us), Inc.
FDA 510(k) clearance K061165 for ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01, Substantially Equivalent on 2006-08-03. Applicant: Sweden Diagnostics (Us), Inc.. Device class: 2.
Clearance details
- Applicant
- Sweden Diagnostics (Us), Inc.
- 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
- Portage, MI, US
Recent devices under product code NHX
view all- K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
- K143754 — QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
- K121576 — IMMULITE 2000 ANTI-CCP IGG ASSAY
- K112810 — MULTI-ANALYTE DETECTION SYSTEMS
- K110296 — AXIS-SHIELD ANTI-CCP
Recalls naming K061165
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 K061165.
Data sourced from openFDA. This site is unofficial and independent of the FDA.