RHEUMAGEN ASO T-CONTROL— 510(k) K904311

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K904311 for RHEUMAGEN ASO T-CONTROL, Substantially Equivalent on 1991-01-25. Applicant: Biokit USA, Inc.. Device class: 1.

Clearance details

Applicant: Biokit USA, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1990-09-19
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT1995-10-20
K915742 — TURBIQUANT ASL1993-06-28
K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT1993-06-15
K924247 — ACCUTEX ASO LATEX TEST1992-12-07

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.