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 |