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FDA 510(k)

IMMULITE 2000 ANTI-CCP IGG ASSAY

K-Number: K121576 · 2013-04-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2013-04-04
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 ANTI-CCP IGG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-04-04 under 510(k) number K121576. 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 IMMULITE 2000 ANTI-CCP IGG ASSAY?

IMMULITE 2000 ANTI-CCP IGG ASSAY is a medical device that received FDA 510(k) clearance on 2013-04-04. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K121576.

When did IMMULITE 2000 ANTI-CCP IGG ASSAY receive FDA 510(k) clearance?

IMMULITE 2000 ANTI-CCP IGG ASSAY received FDA 510(k) clearance on 2013-04-04, under 510(k) number K121576.

Who is the listed applicant for IMMULITE 2000 ANTI-CCP IGG ASSAY?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE 2000 ANTI-CCP IGG ASSAY?

The FDA product code for IMMULITE 2000 ANTI-CCP IGG ASSAY is NHX.

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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 LimitedK112810MULTI-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 LaboratoriesK090753THERATEST EL-ANTI-CCP/2Theratest Laboratories, Inc.

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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