ClearanceBrief
Panels › Microbiology › Product code GTZ · Class 1

Antisera, All Groups, Streptococcus Spp.

Regulation 866.3740

0510(k)s in 12 months (105 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in GTZ

Company510(k)sRecalls
Abbott Laboratories90
Quidel Corp.80
Bd Becton Dickinson Vacutainer Systems Preanalytic70
Binax, Inc.60
Diagnostic Products Corp.40
Pharmacia, Inc.40
Armkel, LLC30
Difco Laboratories, Inc.30
Leeco Diagnostics, Inc.30
Medix Biotech, Inc.30
Decided510(k)Device and applicantCode
Nov 30, 2001K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
Binax, Inc.
GTZ
Nov 8, 2001K011709UNI-GOLD STREP A TEST KIT
Trinity Biotech, Plc, IE
GTZ
Mar 15, 2001K010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
Binax, Inc.
GTZ
Aug 27, 1999K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
Binax, Inc.
GTZ
Mar 3, 1998K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
Abbott Laboratories
GTZ
Jul 23, 1997K962060STREP A OIA MAX
Biostar, Inc.
GTZ
Dec 16, 1996K962296STREPTOLEX-STAT
Unipath , Ltd.
GTZ
Oct 11, 1996K961423OSOM STREP A TEST
Wyntek Diagnostics, Inc.
GTZ
Oct 7, 1996K962146EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
Excel Scientific, Inc.
GTZ
Apr 15, 1996K955108CARDS Q.S. STREP A
Quidel Corp.
GTZ
Mar 22, 1996K960712BINAX STREP A TEST
Binax, Inc.
GTZ
Jan 26, 1996K952819ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
Abbott Laboratories
GTZ
Oct 20, 1995K954257QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
Quidel Corp.
GTZ
Oct 20, 1995K951542DIRECTIGEN 1-2-3 GROUP A STREP TEST
Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ
Sep 8, 1995K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
Medix Biotech, Inc.
GTZ
Aug 30, 1995K935554QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
Syntron Bioresearch, Inc.
GTZ
Aug 30, 1995K935475QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
Syntron Bioresearch, Inc.
GTZ
Aug 14, 1995K945571ABBOTT TEST PACK STREP A TEST
Abbott Laboratories
GTZ
Jan 27, 1995K934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)
Pro-Lab, Inc., CA
GTZ
Nov 28, 1994K942093REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
Medical Diagnostic Technologies, Inc.
GTZ
Jul 18, 1994K934484QUICKVUE IN-LINE ONE-STEP STREP A TEST
Quidel Corp.
GTZ
Jul 18, 1994K932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
Medix Biotech, Inc.
GTZ
Dec 2, 1993K924461STREP A NEGATIVE CONTROL
Pacific Biotech, Inc.
GTZ
Apr 6, 1993K924007QUIKPAC STREP A TEST
Syntron Bioresearch, Inc.
GTZ
Sep 28, 1992K923673PRECISE STREP A
Becton Dickinson Advanced Diagnostics
GTZ
Jul 16, 1992K922345TESTPACK PLUS STREP A
Abbott Laboratories
GTZ
Mar 23, 1992K920565BBL STREP GROUPING KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ
Jan 30, 1992K915758STREP A OIA
Biosearch Medical Products, Inc.
GTZ
Oct 31, 1991K912889OIA STREP A
Biosearch Medical Products, Inc.
GTZ
Aug 7, 1991K912868GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
Quidel Corp.
GTZ
Jul 24, 1991K911417ICON STREP B IMMUNOENZYMETRIC ASSAY
Hybritech, Inc.
GTZ
Mar 29, 1991K910797STREPTEX ACID EXTRACTION KIT
Wellcome Diagnostics
GTZ
Aug 22, 1990K903194REDITEST STREP A TEST KIT
Boehringer Mannheim Corp.
GTZ
May 21, 1990K902038PATHO DX STREP D
Diagnostic Products Corp.
GTZ
May 11, 1990K901274TESTPACK PLUS STREP A
Abbott Laboratories
GTZ
Feb 16, 1990K896265QUIDEL GROUP B STREP TEST
Quidel Corp.
GTZ
Jan 22, 1990K897083VENTRESIGN STREP A TEST
Ventrex Laboratories, Inc.
GTZ
Dec 13, 1989K896221CARDS O.S.(TM) STREP A
Pacific Biotech, Inc.
GTZ
Nov 29, 1989K896109IMMUNOCARD STREP A TEST
Disease Detection International, Inc.
GTZ
Nov 29, 1989K895103ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
Gen-Probe, Inc.
GTZ
Nov 14, 1989K894711ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
Gen-Probe, Inc.
GTZ
Aug 15, 1989K894122LEECO VIS-DISK STREP-A (EIA)
Leeco Diagnostics, Inc.
GTZ
Jun 23, 1989K893422CLEARVIEW STREP A
Unipath , Ltd., GB
GTZ
Mar 27, 1989K890840VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
Adi Diagnostics, Inc., CA
GTZ
Feb 7, 1989K885003BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
Armkel, LLC
GTZ
Dec 22, 1988K884750GROUP A STREP, BETA-STREP
Ampcor, Inc.
GTZ
Oct 12, 1988K883999QUIDEL GROUP A STREP TEST
Quidel Corp.
GTZ
Apr 21, 1988K881457KODAK SURECELL STREP A TEST KIT
Eastman Kodak Company
GTZ
Apr 12, 1988K880483V-TREND STREP A TEST
Texas Immunology, Inc.
GTZ
Mar 3, 1988K880460TARGET STREP A
V-Tech, Inc.
GTZ

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