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)

EUROIMMUN ANTI-CCP ELISA

K-Number: K070789 · 2007-12-31

ApplicantEuroimmun Us, LLC
Decision Date2007-12-31
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ANTI-CCP ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, LLC. It received FDA 510(k) clearance on 2007-12-31 under 510(k) number K070789. 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 EUROIMMUN ANTI-CCP ELISA?

EUROIMMUN ANTI-CCP ELISA is a medical device that received FDA 510(k) clearance on 2007-12-31. The listed applicant is Euroimmun Us, LLC. The 510(k) number is K070789.

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

EUROIMMUN ANTI-CCP ELISA received FDA 510(k) clearance on 2007-12-31, under 510(k) number K070789.

Who is the listed applicant for EUROIMMUN ANTI-CCP ELISA?

The FDA 510(k) record lists Euroimmun Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROIMMUN ANTI-CCP ELISA?

The FDA product code for EUROIMMUN ANTI-CCP ELISA is NHX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Euroimmun Us, LLC 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.

K061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KITK070763EUROIMMUN ANA IFA: HEP-20-10K061408EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KITK060700EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.K051489EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

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.

↑