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FDA 510(k)

MININEPH HUMAN RHEUMATOID FACTOR KIT

K-Number: K041891 · 2004-11-05

ApplicantThe Binding Site
Decision Date2004-11-05
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MININEPH HUMAN RHEUMATOID FACTOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site. It received FDA 510(k) clearance on 2004-11-05 under 510(k) number K041891. 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 MININEPH HUMAN RHEUMATOID FACTOR KIT?

MININEPH HUMAN RHEUMATOID FACTOR KIT is a medical device that received FDA 510(k) clearance on 2004-11-05. The listed applicant is The Binding Site. The 510(k) number is K041891.

When did MININEPH HUMAN RHEUMATOID FACTOR KIT receive FDA 510(k) clearance?

MININEPH HUMAN RHEUMATOID FACTOR KIT received FDA 510(k) clearance on 2004-11-05, under 510(k) number K041891.

Who is the listed applicant for MININEPH HUMAN RHEUMATOID FACTOR KIT?

The FDA 510(k) record lists The Binding Site as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MININEPH HUMAN RHEUMATOID FACTOR KIT?

The FDA product code for MININEPH HUMAN RHEUMATOID FACTOR KIT is DHR.

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Other records listing The Binding Site 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.

K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITK103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSK100455SPAPLUS ANALYZERK092450HUMAN IGD KIT FOR USE ON SPAPLUSK072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERK042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

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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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