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Binax, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K090301BINAXNOW PBP2A TEST, MODEL 890-000April 14, 2010
K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000February 24, 2010
K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTDecember 16, 2009
K091489CLEARVIEW ADVANCED STREP A , MODEL 737-430September 4, 2009
K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010September 1, 2009
K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TESTAugust 12, 2009
K080003BINAXNOW G6PD TESTOctober 23, 2008
K062109BINAXNOW INFLUENZA A & B TESTNovember 9, 2006
K053126BINAXNOW INFLUENZA A & B TESTNovember 30, 2005
K041049BINAXNOW INFLUENZA A & B TESTAugust 10, 2004
K032166BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065October 21, 2003
K021649BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACKSeptember 19, 2002
K021646BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACKSeptember 19, 2002
K021687BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACKSeptember 13, 2002
K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTNovember 30, 2001
K010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTMarch 15, 2001
K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STRAugust 27, 1999
K982238BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN COAugust 21, 1998
K960712BINAX STREP A TESTMarch 22, 1996
K934965BINAX LEGIONELLA URINARY ANTIGEN EIASeptember 20, 1994