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FDA 510(k)

ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01

K-Number: K061165 · 2006-08-03

ApplicantSweden Diagnostics (Us), Inc.
Decision Date2006-08-03
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 is the device name listed in this FDA 510(k) record. The listed applicant is Sweden Diagnostics (Us), Inc.. It received FDA 510(k) clearance on 2006-08-03 under 510(k) number K061165. 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 ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01?

ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 is a medical device that received FDA 510(k) clearance on 2006-08-03. The listed applicant is Sweden Diagnostics (Us), Inc.. The 510(k) number is K061165.

When did ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 receive FDA 510(k) clearance?

ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 received FDA 510(k) clearance on 2006-08-03, under 510(k) number K061165.

Who is the listed applicant for ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01?

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

What is the FDA product code for ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01?

The FDA product code for ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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