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FDA 510(k)

QUANTA LITE CCP3 IGG ELISA

K-Number: K052264 · 2005-11-23

ApplicantInova Diagnostics, Inc.
Decision Date2005-11-23
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE CCP3 IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2005-11-23 under 510(k) number K052264. 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 QUANTA LITE CCP3 IGG ELISA?

QUANTA LITE CCP3 IGG ELISA is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K052264.

When did QUANTA LITE CCP3 IGG ELISA receive FDA 510(k) clearance?

QUANTA LITE CCP3 IGG ELISA received FDA 510(k) clearance on 2005-11-23, under 510(k) number K052264.

Who is the listed applicant for QUANTA LITE CCP3 IGG ELISA?

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

What is the FDA product code for QUANTA LITE CCP3 IGG ELISA?

The FDA product code for QUANTA LITE CCP3 IGG ELISA 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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