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FDA 510(k)

EL-RF/3 (IGM-IGG-IGA) KIT

K-Number: K941398 · 1995-07-28

ApplicantTheratest Laboratories, Inc.
Decision Date1995-07-28
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EL-RF/3 (IGM-IGG-IGA) KIT 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 1995-07-28 under 510(k) number K941398. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EL-RF/3 (IGM-IGG-IGA) KIT?

EL-RF/3 (IGM-IGG-IGA) KIT is a medical device that received FDA 510(k) clearance on 1995-07-28. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K941398.

When did EL-RF/3 (IGM-IGG-IGA) KIT receive FDA 510(k) clearance?

EL-RF/3 (IGM-IGG-IGA) KIT received FDA 510(k) clearance on 1995-07-28, under 510(k) number K941398.

Who is the listed applicant for EL-RF/3 (IGM-IGG-IGA) KIT?

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-RF/3 (IGM-IGG-IGA) KIT?

The FDA product code for EL-RF/3 (IGM-IGG-IGA) KIT is DHR.

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-PR3K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGAK051066THERATEST EL-ANA PROFILES

View all 22 devices →

Related Devices (Code: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.

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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