Binax, Inc. - FDA 510(k) Cleared Devices

Cleared Apr 14, 2010

BINAXNOW PBP2A TEST, MODEL 890-000

K090301 · MYI

Microbiology · 432d

Cleared Feb 24, 2010

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

K091766 · MYI

Microbiology · 252d

Cleared Dec 16, 2009

BINAXNOX STAPHYLOCOCCUS AUREUS TEST

K090964 · JWX

Microbiology · 254d

Cleared Sep 04, 2009

CLEARVIEW ADVANCED STREP A , MODEL 737-430

K091489 · GTY

Microbiology · 107d

Cleared Sep 01, 2009

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

K083744 · MJZ

Microbiology · 259d

Cleared Aug 12, 2009

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

K092223 · PSZ

Microbiology · 20d

Cleared Nov 09, 2006

BINAXNOW INFLUENZA A & B TEST

K062109 · PSZ

Microbiology · 108d

Cleared Nov 30, 2005

BINAXNOW INFLUENZA A & B TEST

K053126 · PSZ

Microbiology · 23d

Cleared Aug 10, 2004

BINAXNOW INFLUENZA A & B TEST

K041049 · PSZ

Microbiology · 110d

Cleared Oct 21, 2003

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY...

K032166 · GQG

Microbiology · 97d

Cleared Sep 19, 2002

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...

K021646 · PSZ

Microbiology · 122d

Cleared Sep 19, 2002

BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...

K021649 · PSZ

Microbiology · 122d