Binax, Inc.
Portland, ME, US
Binax, Inc. appears in FDA device records in Portland, ME. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Binax, Inc. between 1994 and 2004. The busiest year on record is 2002, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041049 | BINAXNOW INFLUENZA A & B TEST | PSZ | Substantially Equivalent | |
| K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 | GQG | Substantially Equivalent | |
| K021649 | BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK | PSZ | Substantially Equivalent | |
| K021646 | BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK | PSZ | Substantially Equivalent | |
| K021687 | BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK | GQG | Substantially Equivalent | |
| K012521 | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST | GTZ | Substantially Equivalent | |
| K010523 | MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST | GTZ | Substantially Equivalent | |
| K991726 | BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI | GTZ | Substantially Equivalent | |
| K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 | MJH | Substantially Equivalent | |
| K960712 | BINAX STREP A TEST | GTZ | Substantially Equivalent | |
| K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA | MJH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain