Cleared Traditional

RHEUMATOID FACTOR-RAPID CARD TEST #65114

K830832 · Emd Chemicals, Inc. · Immunology
Apr 1983
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K830832 is an FDA 510(k) clearance for the RHEUMATOID FACTOR-RAPID CARD TEST #65114, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Emd Chemicals, Inc. (Walker, US). The FDA issued a Cleared decision on April 18, 1983, 33 days after receiving the submission on March 16, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K830832 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1983
Decision Date April 18, 1983
Days to Decision 33 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

Similar Devices — DHR System, Test, Rheumatoid Factor

All 143
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727 · Kamiya Biomedical Company · May 2020
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · Inova Diagnostics, Inc. · Apr 2019
EliA RF IgM Immunoassay
K182747 · Phadia AB · Dec 2018
Optilite Rheumatoid Factor Kit
K162263 · The Binding Site Group , Ltd. · May 2017
Rheumatoid Factor (RF) Kit for use on SPAPLUS
K160070 · The Binding Site Group , Ltd. · Dec 2016
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
K143736 · Immco Diagnostics, Inc. · Sep 2015