Murex Suds Group a Strep

FDA 510(k) K860576 · Murex Corp.

Substantially Equivalent

510(k) numberK860576

Submission

Device name
Murex Suds Group a Strep
Applicant
Murex Corp.
Norcross, GA, US
Received
February 18, 1986
Decision date
April 4, 1986
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
K862048Suds(Hcg)Control Set (Urine&Serum) & HCG Ref.SerumDQX · Traditional 06/19/1986SE
K861458Murex Suds ToxoLGD · Traditional 06/13/1986SE
K861282Murex Suds RubellaLFX · Traditional 06/13/1986SE
K860451Murex (TM), Suds (TM), HCG AssayLCX · Traditional 04/21/1986SE

Questions and answers

When was Murex Suds Group a Strep cleared by the FDA?

Murex Suds Group a Strep (K860576) received a 510(k) decision of Substantially Equivalent on April 4, 1986, 45 days after the submission was received.

What is the product code of K860576?

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