RPR TEST REDITEST— 510(k) K843741

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K843741 for RPR TEST REDITEST, Substantially Equivalent on 1984-10-25. Applicant: Biokit USA, Inc.. Device class: 2.

Clearance details

Applicant: Biokit USA, Inc.
Product code: Code GMP
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1984-09-25
Decision date: 1984-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, Spain, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMP

K980638 — ADI SYPHILIS RPR LIQUID CONTROLS1998-07-06
K961998 — QUALITROL SYPHSERO CONTROL SET1996-08-08
K955143 — RPR LIQUID CONTROLS1996-07-30
K885298 — VISUWELL REAGIN TEST 960 TEST KIT1989-03-15
K875180 — V-TREND RPRL CARD TEST1988-02-04

More clearances from Biokit USA, Inc.

K913467 — TOXOGEN1993-01-11
K910541 — BIOKIT RPR1991-10-18
K904310 — RHEUMAGEN RF T-CONTROL1991-05-31
K910539 — RHEUMAJET RF1991-04-05
K910686 — RHEUMAJET CRP1991-03-19

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