Cromatest Rheumatoid Diagnostic/Rf Latex Test

FDA 510(k) K904498 · Biotrax, Inc.

Substantially Equivalent

510(k) numberK904498

Submission

Device name
Cromatest Rheumatoid Diagnostic/Rf Latex Test
Applicant
Biotrax, Inc.
Baltimore, MD, US
Received
October 2, 1990
Decision date
October 29, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DHR – System, Test, Rheumatoid Factor
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5775
Specialty
Immunology

Other 510(k)s with product code DHR

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K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR · Traditional Kamiya Biomedical Company05/20/2020SE
K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional Inova Diagnostics, Inc.04/17/2019SE
K182747EliA RF IgM ImmunoassayDHR · Traditional Phadia AB12/18/2018SE
K162263Optilite Rheumatoid Factor KitDHR · Traditional The Binding Site Group , Ltd.05/03/2017SE
K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR · Traditional The Binding Site Group , Ltd.12/07/2016SE
K143736ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional Immco Diagnostics, Inc.09/23/2015SE
K102673Rheumatoid Factor Immunological Test SystemDHR · Traditional Phadia US, Inc.09/30/2011SE
K100499Orgentec Rheumatoid Factor EiaDHR · Traditional Orgentec Diagnostika GmbH10/27/2010SE
K083080Igx Plex Rheumatoid Arthritis (Ra) Assay and Sqidworks Diagnostics PlatformDHR · Traditional Sqi Diagnostics Systems10/29/2009SE
K071247N Latex RF KitDHR · Traditional Dade Behring, Inc.08/08/2007SE

More from Dade Behring, Inc.

510(k)DeviceDecision
K904496Cromatest Syphilis DiagnosticGMQ · Traditional 07/24/1991SE
K904416Croatest (R) Rheumatoid DiagnosticGTQ · Traditional 06/24/1991SE
K904497Cromatest Rheumatoid Diagnostic/Crp Latex TestDCN · Traditional 11/01/1990SE

Questions and answers

When was Cromatest Rheumatoid Diagnostic/Rf Latex Test cleared by the FDA?

Cromatest Rheumatoid Diagnostic/Rf Latex Test (K904498) received a 510(k) decision of Substantially Equivalent on October 29, 1990, 27 days after the submission was received.

What is the product code of K904498?

The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.