Diesse RF Test Kit

FDA 510(k) K854222 · Marvic Interpharma, Inc.

Substantially Equivalent

510(k) numberK854222

Submission

Device name
Diesse RF Test Kit
Applicant
Marvic Interpharma, Inc.
Palm Harbor, FL, US
Received
October 18, 1985
Decision date
February 6, 1986
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

510(k)DeviceApplicantDecision
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
K854223Ves-Tec/Ves-MaticCKB · Traditional 04/04/1986SE
K854221Diesse CRP Test KitDCK · Traditional 11/25/1985SE

Questions and answers

When was Diesse RF Test Kit cleared by the FDA?

Diesse RF Test Kit (K854222) received a 510(k) decision of Substantially Equivalent on February 6, 1986, 111 days after the submission was received.

What is the product code of K854222?

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