FDA 510(k) Applications Submitted by Anne Jepson
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080003 |
01/02/2008 |
BINAXNOW G6PD TEST |
BINAX, INC. |
| DEN070006 |
03/23/2007 |
BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX |
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX |
| 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. |
| K092349 |
08/04/2009 |
CLEARVIEW EXACT II INFLUENZA A & B TEST |
INVERNESS MEDICAL, INC. |
| K103610 |
12/09/2010 |
CLEARVIEW EXACT II INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K083744 |
12/16/2008 |
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 |
BINAX, INC. |
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