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FDA 510(k)

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

K-Number: K052133 · 2005-12-12

ApplicantEurodiagnostica
Decision Date2005-12-12
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eurodiagnostica. It received FDA 510(k) clearance on 2005-12-12 under 510(k) number K052133. 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 IMMUNOSCAN RA ANTI-CCP TEST SYSTEM?

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-12. The listed applicant is Eurodiagnostica. The 510(k) number is K052133.

When did IMMUNOSCAN RA ANTI-CCP TEST SYSTEM receive FDA 510(k) clearance?

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM received FDA 510(k) clearance on 2005-12-12, under 510(k) number K052133.

Who is the listed applicant for IMMUNOSCAN RA ANTI-CCP TEST SYSTEM?

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

What is the FDA product code for IMMUNOSCAN RA ANTI-CCP TEST SYSTEM?

The FDA product code for IMMUNOSCAN RA ANTI-CCP TEST SYSTEM is NHX.

Related Clinical Trials

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Other records listing Eurodiagnostica 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.

K051455WIESLAB CAP MPO-ANCAK051458WIESLAB CAP PR-3 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.

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