RHEUMAJET RF— 510(k) K910539

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K910539 for RHEUMAJET RF, Substantially Equivalent on 1991-04-05. 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: 1991-01-28
Decision date: 1991-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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More clearances from Biokit USA, Inc.

K913467 — TOXOGEN1993-01-11
K910541 — BIOKIT RPR1991-10-18
K904310 — RHEUMAGEN RF T-CONTROL1991-05-31
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.