Medical Device Manufacturer · US , S. Portland , ME

Binax, Inc.

30 submissions · 30 cleared · Since 1986
30
Total
30
Cleared
0
Denied

Binax, Inc. — FDA 510(k) Submissions

Binax, Inc. has submitted 30 FDA 510(k) premarket notifications since 1986, of which 30 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antisera, All Groups, Streptococcus Spp., Devices Detecting Influenza A, B, And C Virus Antigens, Legionella, Spp., Elisa, System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies, Assay, Glycosylated Hemoglobin . Use the specialty filter in the sidebar to narrow results.

30 devices
1–25 of 30
BINAXNOW PBP2A TEST, MODEL 890-000
K090301 · MYI System, Test, Genotypic... · Microbiology
Apr 2010 432d
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
K091766 · MYI System, Test, Genotypic... · Microbiology
Feb 2010 252d
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
K090964 · JWX Kit, Screening,... · Microbiology
Dec 2009 254d
CLEARVIEW ADVANCED STREP A , MODEL 737-430
K091489 · GTY Antigens, All Groups,... · Microbiology
Sep 2009 107d
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
K083744 · MJZ Kit, Direct Antigen,... · Microbiology
Sep 2009 259d
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223 · PSZ Devices Detecting... · Microbiology
Aug 2009 20d
BINAXNOW G6PD TEST
K080003 · JBF Glucose-6-phosphate... · Hematology
Oct 2008 295d
BINAXNOW INFLUENZA A & B TEST
K062109 · PSZ Devices Detecting... · Microbiology
Nov 2006 108d
BINAXNOW INFLUENZA A & B TEST
K053126 · PSZ Devices Detecting... · Microbiology
Nov 2005 23d
BINAXNOW INFLUENZA A & B TEST
K041049 · PSZ Devices Detecting... · Microbiology
Aug 2004 110d
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
K032166 · GQG Antigen, Cf (including Cf... · Microbiology
Oct 2003 97d
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
K021646 · PSZ Devices Detecting... · Microbiology
Sep 2002 122d
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
K021649 · PSZ Devices Detecting... · Microbiology
Sep 2002 122d
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
K021687 · GQG Antigen, Cf (including Cf... · Microbiology
Sep 2002 114d
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521 · GTZ Antisera, All Groups,... · Microbiology
Nov 2001 116d
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · GTZ Antisera, All Groups,... · Microbiology
Mar 2001 21d
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
K991726 · GTZ Antisera, All Groups,... · Microbiology
Aug 1999 99d
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
K982238 · MJH Legionella, Spp., Elisa · Microbiology
Aug 1998 57d
BINAX STREP A TEST
K960712 · GTZ Antisera, All Groups,... · Microbiology
Mar 1996 30d
BINAX LEGIONELLA URINARY ANTIGEN EIA
K934965 · MJH Legionella, Spp., Elisa · Microbiology
Sep 1994 340d
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
K912748 · LCP Assay, Glycosylated... · Hematology
Oct 1991 132d
EQUATE(TM) AQR APO AL/B DUO CONTROL
K903122 · DFC Lipoprotein, Low-density,... · Immunology
Aug 1990 17d
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305 · CGJ Radioimmunoassay,... · Chemistry
Oct 1988 63d
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306 · JIT Calibrator, Secondary · Chemistry
Oct 1988 63d
BINAX EQUATE GLYCOHEMOGLOBIN
K874749 · LCP Assay, Glycosylated... · Hematology
Aug 1988 268d
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