Cleared Traditional

RHEUMAGEN RF T-CONTROL

K904310 · Biokit USA, Inc. · Immunology
May 1991
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K904310 is an FDA 510(k) clearance for the RHEUMAGEN RF T-CONTROL, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on May 31, 1991, 254 days after receiving the submission on September 19, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K904310 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1990
Decision Date May 31, 1991
Days to Decision 254 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

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