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FDA 510(k)

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

K-Number: K994338 · 2000-02-03

ApplicantCogent Diagnotics , Ltd.
Decision Date2000-02-03
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Diagnotics , Ltd.. It received FDA 510(k) clearance on 2000-02-03 under 510(k) number K994338. 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 AUTOSTAT II RHEUMATOID FACTOR IGM ELISA?

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA is a medical device that received FDA 510(k) clearance on 2000-02-03. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K994338.

When did AUTOSTAT II RHEUMATOID FACTOR IGM ELISA receive FDA 510(k) clearance?

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA received FDA 510(k) clearance on 2000-02-03, under 510(k) number K994338.

Who is the listed applicant for AUTOSTAT II RHEUMATOID FACTOR IGM ELISA?

The FDA 510(k) record lists Cogent Diagnotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSTAT II RHEUMATOID FACTOR IGM ELISA?

The FDA product code for AUTOSTAT II RHEUMATOID FACTOR IGM ELISA is DHR.

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Other records listing Cogent Diagnotics , Ltd. 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.

K003057AUTOSTAT II ENA-4 PROFILE ELISAK003054AUTOSTAT II ENA-6 PROFILE ELISAK002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAK993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISAK993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISAK993304AUTOSTAT II RHEUMATOID FACTOR IGG ELISA

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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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