Ez Detect, 5 Minute Strep-A Color Test

FDA 510(k) K860923 · Self Care Systems, Inc.

Substantially Equivalent

510(k) numberK860923

Submission

Device name
Ez Detect, 5 Minute Strep-A Color Test
Applicant
Self Care Systems, Inc.
Newport Beach, CA, US
Received
March 11, 1986
Decision date
May 16, 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

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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
K854358Ez Detech-Urine Blood Test SticksKHE · Traditional 04/09/1986SE
K860028Modified Ez Detect Occult Blood Test in StoolKHE · Traditional 04/07/1986SE

Questions and answers

When was Ez Detect, 5 Minute Strep-A Color Test cleared by the FDA?

Ez Detect, 5 Minute Strep-A Color Test (K860923) received a 510(k) decision of Substantially Equivalent on May 16, 1986, 66 days after the submission was received.

What is the product code of K860923?

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