Visuwell Group a Streptococcus Detection Kit

FDA 510(k) K890840 · Adi Diagnostics, Inc.

Substantially Equivalent

510(k) numberK890840

Submission

Device name
Visuwell Group a Streptococcus Detection Kit
Applicant
Adi Diagnostics, Inc.
Rexdale, Ontario, CA
Received
February 21, 1989
Decision date
March 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GTZ – Antisera, All Groups, Streptococcus Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3740
Specialty
Microbiology

Other 510(k)s with product code GTZ

510(k)DeviceApplicantDecision
K012521Binax Now Streptococcus Pneumoniae TestGTZ · Traditional Binax, Inc.11/30/2001SE
K011709Uni-Gold Strep a Test KitGTZ · Traditional Trinity Biotech, Plc11/08/2001SE
K010523Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen TestGTZ · Special Binax, Inc.03/15/2001SE
K991726Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test KIT),(12 Test Kit)…GTZ · Traditional Binax, Inc.08/27/1999SE
K971522Abbott Testpack Plus Strep a with on Board Controls (Obc) IIGTZ · Traditional Abbott Laboratories03/03/1998SE
K962060Strep a Oia MaxGTZ · Traditional Biostar, Inc.07/23/1997SE
K962296Streptolex-StatGTZ · Traditional Unipath , Ltd.12/16/1996SE
K961423Osom Strep a TestGTZ · Traditional Wyntek Diagnostics, Inc.10/11/1996SE
K962146Excel Onestep Group a Strep Antigen Module Test KitGTZ · Traditional Excel Scientific, Inc.10/07/1996SE
K955108Cards Q.S. Strep aGTZ · Traditional Quidel Corp.04/15/1996SE

More from Quidel Corp.

510(k)DeviceDecision
K910487Visuwell Syphilis AntigenLIP · Traditional 06/24/1991SE
K900973Visuwell(R) ChlamydiaLJC · Traditional 05/15/1990SE
K900338Visuwell(R) Reagin Test (Modification)GMQ · Traditional 04/10/1990SE

Questions and answers

When was Visuwell Group a Streptococcus Detection Kit cleared by the FDA?

Visuwell Group a Streptococcus Detection Kit (K890840) received a 510(k) decision of Substantially Equivalent on March 27, 1989, 34 days after the submission was received.

What is the product code of K890840?

The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.