Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EDIA ANTI-CCP

K-Number: K062045 · 2006-12-04

ApplicantEuro-Diagnostica AB
Decision Date2006-12-04
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EDIA ANTI-CCP is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Diagnostica AB. It received FDA 510(k) clearance on 2006-12-04 under 510(k) number K062045. The device is classified under product code NHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDIA ANTI-CCP?

EDIA ANTI-CCP is a medical device that received FDA 510(k) clearance on 2006-12-04. The listed applicant is Euro-Diagnostica AB. The 510(k) number is K062045.

When did EDIA ANTI-CCP receive FDA 510(k) clearance?

EDIA ANTI-CCP received FDA 510(k) clearance on 2006-12-04, under 510(k) number K062045.

Who is the listed applicant for EDIA ANTI-CCP?

The FDA 510(k) record lists Euro-Diagnostica AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDIA ANTI-CCP?

The FDA product code for EDIA ANTI-CCP is NHX.

Other records listing Euro-Diagnostica AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093908CCPOINTK091657IMMUNOSCAN CCPLUSK971689IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KITK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITK971690IMMUNOSCAN PR3-ANCA

Related Devices (Code: NHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.Axis-Shield Diagnostics LimitedK121576IMMULITE 2000 ANTI-CCP IGG ASSAYSiemens Healthcare Diagnostics, Inc.K112810MULTI-ANALYTE DETECTION SYSTEMSBio-Rad LaboratoriesK110296AXIS-SHIELD ANTI-CCPAxis-Shield Diagnostics, Ltd.K093908CCPOINTEuro-Diagnostica ABK093954BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑