Binax, Inc.
Scarborough, ME, US
Binax, Inc. appears in FDA device records in Scarborough, ME. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Binax, Inc. between 2005 and 2010. The busiest year on record is 2009, with 4. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 | MYI | Substantially Equivalent | |
| K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | MYI | Substantially Equivalent | |
| K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | JWX | Substantially Equivalent | |
| K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 | GTY | Substantially Equivalent | |
| K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | MJZ | Substantially Equivalent | |
| K092223 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST | PSZ | Substantially Equivalent | |
| K080003 | BINAXNOW G6PD TEST | JBF | Substantially Equivalent | |
| K062109 | BINAXNOW INFLUENZA A & B TEST | PSZ | Substantially Equivalent | |
| K053126 | BINAXNOW INFLUENZA A & B TEST | PSZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GTYAntigens, All Groups, Streptococcus Spp.
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- MJZKit, Direct Antigen, Positive Control
- JWXKit, Screening, Staphylococcus Aureus
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Binax, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Binax, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain