Strep a Oia Max

FDA 510(k) K962060 · Biostar, Inc.

Substantially Equivalent

510(k) numberK962060

Submission

Device name
Strep a Oia Max
Applicant
Biostar, Inc.
Boulder, CO, US
Received
May 28, 1996
Decision date
July 23, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K960712Binax Strep a TestGTZ · Traditional Binax, Inc.03/22/1996SE

More from Binax, Inc.

510(k)DeviceDecision
K991829Cdtox a OiaLLH · Traditional 11/02/1999SE
K991828Strep B OiaGTY · Traditional 08/19/1999SE
K981651AB Flu OiaPSZ · Traditional 11/25/1998SE
K951010Chlamydia OiaLJC · Traditional 10/07/1995SE
K936112Strep B OiaGTY · Traditional 07/06/1994SE

Questions and answers

When was Strep a Oia Max cleared by the FDA?

Strep a Oia Max (K962060) received a 510(k) decision of Substantially Equivalent on July 23, 1997, 421 days after the submission was received.

What is the product code of K962060?

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