Binax, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Binax, Inc.” (first 1986, latest 2010), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | 6 | 6 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 6 | 6 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| MJH | Legionella, Spp., Elisa | 2 | 2 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 2 | 2 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
Plus 6 more product codes.
Review panels
- Microbiology (21)
- Clinical Chemistry (5)
- Hematology (3)
- Immunology (1)
Most recent Binax, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 | MYI | 2010-04-14 | 432 |
| K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | MYI | 2010-02-24 | 252 |
| K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | JWX | 2009-12-16 | 254 |
| K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 | GTY | 2009-09-04 | 107 |
| K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | MJZ | 2009-09-01 | 259 |
| K092223 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST | PSZ | 2009-08-12 | 20 |
| K080003 | BINAXNOW G6PD TEST | JBF | 2008-10-23 | 295 |
| K062109 | BINAXNOW INFLUENZA A & B TEST | PSZ | 2006-11-09 | 108 |
| K053126 | BINAXNOW INFLUENZA A & B TEST | PSZ | 2005-11-30 | 23 |
| K041049 | BINAXNOW INFLUENZA A & B TEST | PSZ | 2004-08-10 | 110 |
20 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-02-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Binax, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Binax, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Binax, Inc.” (first 1986, latest 2010), across 16 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Binax, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Binax, Inc. is 108 days.
Which FDA product codes appear under Binax, Inc.?
The most frequent FDA product codes under this applicant name are 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, 2).
Next steps
- See all 30 Binax, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GTZ, Binax, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.