Cleared Traditional

IMMUNOSCAN CCPLUS

K091657 · Euro-Diagnostica AB · Immunology

Nov 2009

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K091657 is an FDA 510(k) clearance for the IMMUNOSCAN CCPLUS, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Euro-Diagnostica AB (Malmo, SE). The FDA issued a Cleared decision on November 19, 2009, 163 days after receiving the submission on June 9, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K091657 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2009
Decision Date	November 19, 2009
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	NHX — Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5775
Definition	The Device Is Used For The Detection Of Anti-cyclic Citrullinated Peptide (ccp) Antibodies In Human Serum Or Plasma As An Aid In The Diagnosis Of Rheumatoid Arthritis.