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Binax, Inc.

30 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
BINAXNOW PBP2A TEST, MODEL 890-000 (K090301)Binax, Inc.2010-04-14
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (K091766)Binax, Inc.2010-02-24
BINAXNOX STAPHYLOCOCCUS AUREUS TEST (K090964)Binax, Inc.2009-12-16
CLEARVIEW ADVANCED STREP A , MODEL 737-430 (K091489)Binax, Inc.2009-09-04
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (K083744)Binax, Inc.2009-09-01
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (K092223)Binax, Inc.2009-08-12
BINAXNOW G6PD TEST (K080003)Binax, Inc.2008-10-23
BINAXNOW INFLUENZA A & B TEST (K062109)Binax, Inc.2006-11-09
BINAXNOW INFLUENZA A & B TEST (K053126)Binax, Inc.2005-11-30
BINAXNOW INFLUENZA A & B TEST (K041049)Binax, Inc.2004-08-10
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166)Binax, Inc.2003-10-21
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK (K021646)Binax, Inc.2002-09-19
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK (K021649)Binax, Inc.2002-09-19
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK (K021687)Binax, Inc.2002-09-13
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (K012521)Binax, Inc.2001-11-30
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (K010523)Binax, Inc.2001-03-15
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI (K991726)Binax, Inc.1999-08-27
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 (K982238)Binax, Inc.1998-08-21
BINAX STREP A TEST (K960712)Binax, Inc.1996-03-22
BINAX LEGIONELLA URINARY ANTIGEN EIA (K934965)Binax, Inc.1994-09-20
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT (K912748)Binax, Inc.1991-10-31
EQUATE(TM) AQR APO AL/B DUO CONTROL (K903122)Binax, Inc.1990-08-02
BINAS LUTEINIZING HORMONE IRMA TEST KIT (K883306)Binax, Inc.1988-10-06
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY (K883305)Binax, Inc.1988-10-06
BINAX EQUATE GLYCOHEMOGLOBIN (K874749)Binax, Inc.1988-08-12
BINAX PROLACTIN IRMA DIAGNOSTIC KIT (K880218)Binax, Inc.1988-03-01
BINAX EQUATE STREP B (K872904)Binax, Inc.1987-11-20
BINAX L.S. TSH IRMA TEST KIT (K873303)Binax, Inc.1987-10-02
BINAX IRMA TOTAL BETA-HCG TEST KIT (K872728)Binax, Inc.1987-08-05
BINAX STREP A (K863908)Binax, Inc.1986-12-22

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