VISUWELL(R) REAGIN TEST (MODIFICATION)— 510(k) K900338

Name: FDA 510(k) clearance K900338
Creator: U.S. Food and Drug Administration
Published: 1990-04-10

Substantially Equivalent

Adi Diagnostics, Inc.

FDA 510(k) clearance K900338 for VISUWELL(R) REAGIN TEST (MODIFICATION), Substantially Equivalent on 1990-04-10. Applicant: Adi Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Adi Diagnostics, Inc.
Product code: Code GMQ
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1990-01-23
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rexdale, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMQ

view all

K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System2025-10-10
K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer2020-10-21
K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution2018-11-30
K173376 — ASI Evolution2018-06-14
K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System2015-11-12

More clearances from Adi Diagnostics, Inc.

view all

K910487 — VISUWELL SYPHILIS ANTIGEN1991-06-24
K900973 — VISUWELL(R) CHLAMYDIA1990-05-15
K890840 — VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT1989-03-27

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