FDA 510(k) Applications Submitted by BINAX, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K092223 |
07/23/2009 |
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K062109 |
07/24/2006 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K053126 |
11/07/2005 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K080003 |
01/02/2008 |
BINAXNOW G6PD TEST |
BINAX, INC. |
| K021646 |
05/20/2002 |
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK |
BINAX, INC. |
| K021649 |
05/20/2002 |
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK |
BINAX, INC. |
| K021687 |
05/22/2002 |
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK |
BINAX, INC. |
| K083744 |
12/16/2008 |
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 |
BINAX, INC. |
| K091489 |
05/20/2009 |
CLEARVIEW ADVANCED STREP A , MODEL 737-430 |
BINAX, INC. |
| K041049 |
04/22/2004 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K032166 |
07/16/2003 |
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 |
BINAX, INC. |
| K012521 |
08/06/2001 |
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST |
BINAX, INC. |
| K960712 |
02/21/1996 |
BINAX STREP A TEST |
BINAX, INC. |
| K010523 |
02/22/2001 |
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST |
BINAX, INC. |
| K991726 |
05/20/1999 |
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI |
BINAX, INC. |
| K982238 |
06/25/1998 |
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 |
BINAX, INC. |
| K090301 |
02/06/2009 |
BINAXNOW PBP2A TEST, MODEL 890-000 |
BINAX, INC. |
| K090964 |
04/06/2009 |
BINAXNOX STAPHYLOCOCCUS AUREUS TEST |
BINAX, INC. |
| K091766 |
06/17/2009 |
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 |
BINAX, INC. |
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