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FDA 510(k)

THERATEST EL-ANTI-CCP/2

K-Number: K090753 · 2010-03-05

ApplicantTheratest Laboratories, Inc.
Decision Date2010-03-05
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THERATEST EL-ANTI-CCP/2 is the device name listed in this FDA 510(k) record. The listed applicant is Theratest Laboratories, Inc.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K090753. 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 THERATEST EL-ANTI-CCP/2?

THERATEST EL-ANTI-CCP/2 is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K090753.

When did THERATEST EL-ANTI-CCP/2 receive FDA 510(k) clearance?

THERATEST EL-ANTI-CCP/2 received FDA 510(k) clearance on 2010-03-05, under 510(k) number K090753.

Who is the listed applicant for THERATEST EL-ANTI-CCP/2?

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

What is the FDA product code for THERATEST EL-ANTI-CCP/2?

The FDA product code for THERATEST EL-ANTI-CCP/2 is NHX.

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Other records listing Theratest Laboratories, Inc. 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.

K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120K071692THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMSK061376EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGAK051066THERATEST EL-ANA PROFILESK040291EL-ANA PROFILES: ANTI-CHROMATIN

View all 22 devices →

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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