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FDA 510(k)

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP

K-Number: K081338 · 2008-09-11

ApplicantRoche Diagnostics
Decision Date2008-09-11
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2008-09-11 under 510(k) number K081338. 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 ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP?

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Roche Diagnostics. The 510(k) number is K081338.

When did ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP receive FDA 510(k) clearance?

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP received FDA 510(k) clearance on 2008-09-11, under 510(k) number K081338.

Who is the listed applicant for ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP?

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

What is the FDA product code for ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP?

The FDA product code for ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP 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 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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