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FDA 510(k)

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA

K-Number: K060176 · 2006-02-07

ApplicantTheratest Laboratories, Inc.
Decision Date2006-02-07
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA 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 2006-02-07 under 510(k) number K060176. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EL-ACL SCREEN; EL-ACL IGM, IGG, IGA?

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA is a medical device that received FDA 510(k) clearance on 2006-02-07. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K060176.

When did EL-ACL SCREEN; EL-ACL IGM, IGG, IGA receive FDA 510(k) clearance?

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA received FDA 510(k) clearance on 2006-02-07, under 510(k) number K060176.

Who is the listed applicant for EL-ACL SCREEN; EL-ACL IGM, IGG, IGA?

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 EL-ACL SCREEN; EL-ACL IGM, IGG, IGA?

The FDA product code for EL-ACL SCREEN; EL-ACL IGM, IGG, IGA is MID.

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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.

K090753THERATEST EL-ANTI-CCP/2K090760THERATEST 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-PR3K051066THERATEST EL-ANA PROFILESK040291EL-ANA PROFILES: ANTI-CHROMATIN

View all 22 devices →

Related Devices (Code: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-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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