IMMUNOSCAN CCPLUS— 510(k) K091657

Substantially Equivalent

Euro-Diagnostica AB

FDA 510(k) clearance K091657 for IMMUNOSCAN CCPLUS, Substantially Equivalent on 2009-11-19. Applicant: Euro-Diagnostica AB. Device class: 2.

Clearance details

Applicant: Euro-Diagnostica AB
Product code: Code NHX
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2009-06-09
Decision date: 2009-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malmo, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHX

More clearances from Euro-Diagnostica AB

K093908 — CCPOINT2010-12-01
K062045 — EDIA ANTI-CCP2006-12-04
K971464 — IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT1997-10-29
K971689 — IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT1997-10-29
K971690 — IMMUNOSCAN PR3-ANCA1997-10-29

Recalls naming K091657

K-number listed on FDA's recall record

Z-2918-2018 — Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.Class II·Terminated·Euro Diagnostica AB·20160214

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091657.

Data sourced from openFDA. This site is unofficial and independent of the FDA.