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

FDA 510(k) Number Applicant Device Name Decision Date
K823569 ABBOTT LABORATORIES ABBOTT LABORATORIES STREP A EIA 03/01/1983
K852266 ABBOTT LABORATORIES ABBOTT STREP A P.S.D. 12/05/1985
K945571 ABBOTT LABORATORIES ABBOTT TEST PACK STREP A TEST 08/14/1995
K952819 ABBOTT LABORATORIES ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) 01/26/1996
K971522 ABBOTT LABORATORIES ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II 03/03/1998
K850256 ABBOTT LABORATORIES CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES 04/08/1985
K850831 ABBOTT LABORATORIES STREP A QUICK 04/08/1985
K922345 ABBOTT LABORATORIES TESTPACK PLUS STREP A 07/16/1992
K901274 ABBOTT LABORATORIES TESTPACK PLUS STREP A 05/11/1990
K890840 ADI DIAGNOSTICS, INC. VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT 03/27/1989
K880665 ALLELIX DIAGNOSTICS, INC. MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT 03/01/1988
K871620 ALLELIX, INC. ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT 06/17/1987
K854447 AMERICAN MICRO SCAN IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST 01/03/1986
K884750 AMPCOR, INC. GROUP A STREP, BETA-STREP 12/22/1988
K843590 ANTIBODIES INC. DETECT-A-STREP 10/30/1984
K850772 ARMKEL, LLC. BACTIGEN GROUP B STREPTOCOCCUS TEST 05/29/1985
K872114 ARMKEL, LLC. BACTIGEN GROUP B STREPTOCOCCUS-CS TEST 08/27/1987
K885003 ARMKEL, LLC. BACTIGEN(R) GROUP B STREPTOCOCCUS TEST 02/07/1989
K920565 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BBL STREP GROUPING KIT 03/23/1992
K951542 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DIRECTIGEN 1-2-3 GROUP A STREP TEST 10/20/1995
K872493 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST 08/24/1987
K860768 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DIRECTIGEN COMBO MENINGITIS TEST 05/13/1986
K843713 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DIRECTIGEN GROUP A STREP TEST KIT 01/04/1985
K831991 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DIRECTIGEN GROUP B STREP TEST KIT-SERUM 09/26/1983
K870155 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST 03/10/1987
K923673 BECTON DICKINSON ADVANCED DIAGNOSTICS PRECISE STREP A 09/28/1992
K872904 BINAX, INC. BINAX EQUATE STREP B 11/20/1987
K012521 BINAX, INC. BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST 11/30/2001
K991726 BINAX, INC. BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI 08/27/1999
K863908 BINAX, INC. BINAX STREP A 12/22/1986
K960712 BINAX, INC. BINAX STREP A TEST 03/22/1996
K010523 BINAX, INC. MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST 03/15/2001
K912889 BIOSEARCH MEDICAL PRODUCTS, INC. OIA STREP A 10/31/1991
K915758 BIOSEARCH MEDICAL PRODUCTS, INC. STREP A OIA 01/30/1992
K962060 BIOSTAR, INC. STREP A OIA MAX 07/23/1997
K903194 BOEHRINGER MANNHEIM CORP. REDITEST STREP A TEST KIT 08/22/1990
K781607 BURROUGHS WELLCOME CO. STREP-TEX 10/17/1978
K820069 BURROUGHS WELLCOME CO. WELLCOGEN GROUP B 02/18/1982
K842383 DIAGNOSTIC PRODUCTS CORP. PATHO DX LATEX AGGLUTINATION STREP A 07/02/1984
K845022 DIAGNOSTIC PRODUCTS CORP. PATHO DX LATEX AGGLUTINATION STREP B KIT 05/02/1985
K871831 DIAGNOSTIC PRODUCTS CORP. PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT 06/17/1987
K902038 DIAGNOSTIC PRODUCTS CORP. PATHO DX STREP D 05/21/1990
K870854 DIFCO LABORATORIES, INC. BACTO(R) STREP GROUP KIT 04/28/1987
K834582 DIFCO LABORATORIES, INC. DETECT GROUP A STREP TEST 04/04/1984
K854978 DIFCO LABORATORIES, INC. DIFCO STREP A LATEX TEST 03/18/1986
K896109 DISEASE DETECTION INTERNATIONAL, INC. IMMUNOCARD STREP A TEST 11/29/1989
K881457 EASTMAN KODAK COMPANY KODAK SURECELL STREP A TEST KIT 04/21/1988
K962146 EXCEL SCIENTIFIC, INC. EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT 10/07/1996
K760033 GAMMA BIOLOGICALS, INC. TEST, ANTIBODIES FOR GRP A, LATEX SLIDE 08/03/1976
K895103 GEN-PROBE, INC. ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION 11/29/1989
K894711 GEN-PROBE, INC. ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. 11/14/1989
K911417 HYBRITECH, INC. ICON STREP B IMMUNOENZYMETRIC ASSAY 07/24/1991
K860778 HYBRITECH, INC. TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT 04/04/1986
K864170 LEECO DIAGNOSTICS, INC. LEECO VIS-CUBE STREP A (EIA) 02/03/1987
K894122 LEECO DIAGNOSTICS, INC. LEECO VIS-DISK STREP-A (EIA) 08/15/1989
K860947 LEECO DIAGNOSTICS, INC. LEECO-SCREEN, STREP A (EIA) 05/13/1986
K853073 MARION LABORATORIES, INC. CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. 08/01/1985
K860247 MEAD JOHNSON & CO. INSTA KIT FOR GROUP A STREP ID 03/04/1986
K942093 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST 11/28/1994
K932482 MEDIX BIOTECH, INC. MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 07/18/1994
K952873 MEDIX BIOTECH, INC. MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) 09/08/1995
K872346 MEDIX BIOTECH, INC. SURE-STREP A TEST KIT CATALOG NO. MB-1083 09/30/1987
K821100 MERIDIAN DIAGNOSTICS, INC. MERITECASTREP (TM) 05/13/1982
K860576 MUREX CORP. MUREX SUDS GROUP A STREP 04/04/1986
K851132 NEW HORIZONS DIAGNOSTICS CO. LATEX AGGLUTINATION TEST 07/05/1985
K874761 NEW HORIZONS DIAGNOSTICS CO. RAPID COLORIMETRIC DIRECT STREP A TEST 02/19/1988
K801159 ORGANON, INC. STREPTO-SEC TM 06/20/1980
K844399 ORION DIAGNOSTICA, INC. RESPIRALEX LATEX AGGLUTINATION TEST 01/08/1985
K854929 OXOID U.S.A., INC. OXOID STREPTOCOCAL GROUPING KIT 03/11/1986
K896221 PACIFIC BIOTECH, INC. CARDS O.S.(TM) STREP A 12/13/1989
K863647 PACIFIC BIOTECH, INC. CARDS(TM) STREP A CATALOG NO. CR-7545 11/26/1986
K924461 PACIFIC BIOTECH, INC. STREP A NEGATIVE CONTROL 12/02/1993
K800159 PHARMACIA, INC. PHADEBACT STREP D TEST 04/29/1980
K830445 PHARMACIA, INC. PHADEBACT STREP F TEST 04/27/1983
K854150 PHARMACIA, INC. PHADIRECT STREP A TEST 10/23/1985
K844107 PHARMACIA, INC. PHARMACIA STREP A DIRECT SWAB TEST 11/27/1984
K934383 PRO-LAB, INC. PROLEX (STREPTOCCAL GROUPING LATEX KIT) 01/27/1995
K955108 QUIDEL CORP. CARDS Q.S. STREP A 04/15/1996
K912868 QUIDEL CORP. GROUP A STREP POSITIVE AND NEGATIVE CONTROLS 08/07/1991
K872961 QUIDEL CORP. QTEST STREP 09/29/1987
K954257 QUIDEL CORP. QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) 10/20/1995
K934484 QUIDEL CORP. QUICKVUE IN-LINE ONE-STEP STREP A TEST 07/18/1994
K883999 QUIDEL CORP. QUIDEL GROUP A STREP TEST 10/12/1988
K896265 QUIDEL CORP. QUIDEL GROUP B STREP TEST 02/16/1990
K852806 QUIDEL CORP. QUIDEL QUEST STREP GROUP A TEST 07/30/1985
K801775 SACKS FARMS BIOLOGICAL PRODUCTS SERO STREP KIT 10/10/1980
K790492 SCOTT LABORATORIES, INC. SERO-STAT STREPTOCOCCUS TEST 05/01/1979
K860923 SELF CARE SYSTEMS, INC. EZ DETECT, 5 MINUTE STREP-A COLOR TEST 05/16/1986
K852841 SMITH KLINE DIAGNOSTICS, INC. RAPID DIRECT STREP A LATEX AGGLUTINATION TEST 07/24/1985
K861098 SYN-KIT, INC. SEROIDEN STREPTO KIT 'EIKEN' 08/12/1986
K873784 SYNBIOTICS CORP. NOVA STREP A 11/12/1987
K935554 SYNTRON BIORESEARCH, INC. QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY 08/30/1995
K924007 SYNTRON BIORESEARCH, INC. QUIKPAC STREP A TEST 04/06/1993
K935475 SYNTRON BIORESEARCH, INC. QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU 08/30/1995
K880483 TEXAS IMMUNOLOGY, INC. V-TREND STREP A TEST 04/12/1988
K011709 TRINITY BIOTECH, PLC UNI-GOLD STREP A TEST KIT 11/08/2001
K893422 UNIPATH LTD. CLEARVIEW STREP A 06/23/1989
K962296 UNIPATH LTD. STREPTOLEX-STAT 12/16/1996
K880460 V-TECH, INC. TARGET STREP A 03/03/1988
K844855 VENTREX LABORATORIES, INC. VENTRESCREEN STREP A TEST 01/16/1985
K897083 VENTREX LABORATORIES, INC. VENTRESIGN STREP A TEST 01/22/1990
K864206 WELLCOME DIAGNOSTICS REVEAL COLOUR STREP A ZL16 01/13/1987
K910797 WELLCOME DIAGNOSTICS STREPTEX ACID EXTRACTION KIT 03/29/1991
K842827 WELLCOME DIAGNOSTICS STREPTEX DIRECT A ZL14 08/16/1984
K961423 WYNTEK DIAGNOSTICS, INC. OSOM STREP A TEST 10/11/1996


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