Company ยท US
Binax, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2010. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | 6 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 6 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 3 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| MJH | Legionella, Spp., Elisa | 2 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 2 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JIT | Calibrator, Secondary | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 |
| MJZ | Kit, Direct Antigen, Positive Control | 1 |
| NED | 1 | |
| NES | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2010 | K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 Binax, Inc. | MYI |
| Feb 24, 2010 | K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 Binax, Inc. | MYI |
| Dec 16, 2009 | K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST Binax, Inc. | JWX |
| Sep 4, 2009 | K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 Binax, Inc. | GTY |
| Sep 1, 2009 | K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 Binax, Inc. | MJZ |
| Aug 12, 2009 | K092223 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Oct 23, 2008 | K080003 | BINAXNOW G6PD TEST Binax, Inc. | JBF |
| Nov 9, 2006 | K062109 | BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Nov 30, 2005 | K053126 | BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Aug 10, 2004 | K041049 | BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Oct 21, 2003 | K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 Binax, Inc. | GQG |
| Sep 19, 2002 | K021649 | BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK Binax, Inc. | PSZ |
| Sep 19, 2002 | K021646 | BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK Binax, Inc. | PSZ |
| Sep 13, 2002 | K021687 | BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK Binax, Inc. | GQG |
| Nov 30, 2001 | K012521 | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST Binax, Inc. | GTZ |
| Mar 15, 2001 | K010523 | MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST Binax, Inc. | GTZ |
| Aug 27, 1999 | K991726 | BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI Binax, Inc. | GTZ |
| Aug 21, 1998 | K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 Binax, Inc. | MJH |
| Mar 22, 1996 | K960712 | BINAX STREP A TEST Binax, Inc. | GTZ |
| Sep 20, 1994 | K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA Binax, Inc. | MJH |
| Oct 31, 1991 | K912748 | BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT Binax, Inc. | LCP |
| Aug 2, 1990 | K903122 | EQUATE(TM) AQR APO AL/B DUO CONTROL Binax, Inc. | DFC |
| Oct 6, 1988 | K883306 | BINAS LUTEINIZING HORMONE IRMA TEST KIT Binax, Inc. | JIT |
| Oct 6, 1988 | K883305 | BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY Binax, Inc. | CGJ |
| Aug 12, 1988 | K874749 | BINAX EQUATE GLYCOHEMOGLOBIN Binax, Inc. | LCP |
| Mar 1, 1988 | K880218 | BINAX PROLACTIN IRMA DIAGNOSTIC KIT Binax, Inc. | CFT |
| Nov 20, 1987 | K872904 | BINAX EQUATE STREP B Binax, Inc. | GTZ |
| Oct 2, 1987 | K873303 | BINAX L.S. TSH IRMA TEST KIT Binax, Inc. | JLW |
| Aug 5, 1987 | K872728 | BINAX IRMA TOTAL BETA-HCG TEST KIT Binax, Inc. | JHI |
| Dec 22, 1986 | K863908 | BINAX STREP A Binax, Inc. | GTZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Binax, Inc. NOW Malaria (Export use only)
Item Number 660-430, Kit Number 66005,
Kit Number 660-000 Terminated |
NED | None listed |
| Jul 20, 2004 | Binax, Inc. NOW Filariasis Rapid test for W. bancrofti antigen. (Export use only)
Item Number 620-430, Kit Number 620-000, Terminated |
NES | None listed |
| Jul 20, 2004 | Binax, Inc. NOW RSV Test
Item Number 430-430, Kit Number 430-00R Terminated |
GQG | K032166 |