Sero Strep Kit

FDA 510(k) K801775 · Sacks Farms Biological Products

Substantially Equivalent

510(k) numberK801775

Submission

Device name
Sero Strep Kit
Applicant
Sacks Farms Biological Products
Mchenry, IL, US
Received
July 28, 1980
Decision date
October 10, 1980
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
K802995Trypticase Soy Agar W/5% Sheep Bld. CellJSH · Traditional 12/22/1980SE
K802994Trypticase Soy Agar W/5% Rabbit Bld. CelJSH · Traditional 12/22/1980SE

Questions and answers

When was Sero Strep Kit cleared by the FDA?

Sero Strep Kit (K801775) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 74 days after the submission was received.

What is the product code of K801775?

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