RHEUMAGEN RF T-CONTROL— 510(k) K904310

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K904310 for RHEUMAGEN RF T-CONTROL, Substantially Equivalent on 1991-05-31. Applicant: Biokit USA, Inc.. Device class: 2.

Clearance details

Applicant: Biokit USA, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1990-09-19
Decision date: 1991-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHR

K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)2020-05-20
K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents2019-04-17
K182747 — EliA RF IgM Immunoassay2018-12-18
K162263 — Optilite Rheumatoid Factor Kit2017-05-03
K160070 — Rheumatoid Factor (RF) Kit for use on SPAPLUS2016-12-07

More clearances from Biokit USA, Inc.

K913467 — TOXOGEN1993-01-11
K910541 — BIOKIT RPR1991-10-18
K910539 — RHEUMAJET RF1991-04-05
K910686 — RHEUMAJET CRP1991-03-19
K904311 — RHEUMAGEN ASO T-CONTROL1991-01-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.