Insta Kit for Group a Strep Id

FDA 510(k) K860247 · Mead Johnson & Co.

Substantially Equivalent

510(k) numberK860247

Submission

Device name
Insta Kit for Group a Strep Id
Applicant
Mead Johnson & Co.
Evansville, IN, US
Received
January 24, 1986
Decision date
March 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

Questions and answers

When was Insta Kit for Group a Strep Id cleared by the FDA?

Insta Kit for Group a Strep Id (K860247) received a 510(k) decision of Substantially Equivalent on March 4, 1986, 39 days after the submission was received.

What is the product code of K860247?

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