FDA 510(k) Applications for Medical Device Product Code "GTY"
(Antigens, All Groups, Streptococcus Spp.)

FDA 510(k) Number Applicant Device Name Decision Date
K010582 ACON LABORATORIES CO. ACON STREP A RAPID TEST STRIP 05/07/2001
K023766 ACON LABORATORIES CO. ACON STREP A TWIST TEST DEVICE 02/10/2003
K031784 ACON LABORATORIES, INC. ACON STREP A RAPID TEST DEVICE 07/14/2003
K122718 Becton, Dickinson and Company BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP 02/06/2013
K091489 BINAX, INC. CLEARVIEW ADVANCED STREP A , MODEL 737-430 09/04/2009
K991828 BIOSTAR, INC. STREP B OIA 08/19/1999
K133343 Guangzhou Wondfo Biotech Co., Ltd. WONDFO RAPID STREP A TEST 01/31/2014
K212623 Healgen Scientific, LLC Healgen Strep A Rapid Test Strip (Throat Swab) 03/16/2022
K971349 PRINCETON BIOMEDITECH CORP. BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST 07/07/1997
K983386 PRINCETON BIOMEDITECH CORP. BIOSTREP A-DIRECT STREP A ANTIGEN TEST 11/25/1998
K082661 PRINCETON BIOMEDITECH CORP. BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A 10/06/2008
K040708 PRINCETON BIOMEDITECH CORP. STATUS FIRST STREP A 11/22/2004
K011097 QUIDEL CORP. QUICKVUE DIPSTICK STREP A 05/08/2001
K141775 QUIDEL CORPORATION SOFIA (R) STREP A+ FIA 12/16/2014
K123793 QUIDEL CORPORATION SOFIA STREP A FIA 06/17/2013
K171976 Quidel Corporation Sofia Strep A+ FIA, Sofia 2 Analyzer 12/21/2017
K993456 SA SCIENTIFIC, INC. SAS STREP A TEST 03/07/2000
K013379 SA SCIENTIFIC, INC. SAS STREPALERT 12/12/2001
K023270 SA SCIENTIFIC, INC. SAS STREPALERT 10/17/2002
K982373 TRINITY BIOTECH, PLC UNI-GOLD STREP A TEST KIT 02/11/1999
K051638 UNIPATH LTD. INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC 12/06/2005
K992658 WYNTEK DIAGNOSTICS, INC. OSOM ULTRA STREP A TEST, MODEL 147 01/18/2000


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