Data / Medical devices / United States / Abbott Diagnostics Scarborough, Inc.
Abbott Diagnostics Scarborough, Inc.: FDA-registered device maker in Westbrook, ME, United States, 12 510(k) clearances
Abbott Diagnostics Scarborough, Inc. is registered with the FDA (registration 3017662853) in Westbrook, ME, United States. It lists 12 device types. The FDA files 12 510(k) clearances under its listings, the newest dated February 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017662853
- Address
- 5 Bradley Dr, Westbrook, ME, United States, 04092
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Alere BinaxNOW Influenza A & B Card 2, Alere BinaxNOW Legionlla Urinary Antigen Card, Alere BinaxNOW RSV Card, Alere BinaxNOW Strep A Card, Alere BinaxNOW Streptococcus pneumoniae Antigen Card, Alere Determine HIV-1/2 Ag/Ab Combo, Alere Determine HIV-1/2 Ag/Ab Combo Controls, Alere Reader and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 11, 2025 | K243518 | BinaxNOW COVID-19 Antigen Self Test | QYT | Substantially Equivalent | Abbott Diagnostics Scarborough, Inc. | accessdata.fda.gov |
| January 13, 2025 | K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | SCA | Substantially Equivalent | Osang, LLC | accessdata.fda.gov |
| April 10, 2017 | K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | PSZ | Substantially Equivalent | Alere Scarborough, Inc. | accessdata.fda.gov |
| September 3, 2014 | K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST | MYI | Substantially Equivalent | Alere Scarborough, Inc. | accessdata.fda.gov |
| September 1, 2009 | K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | MJZ | Substantially Equivalent | Binax, Inc. | accessdata.fda.gov |
| October 23, 2008 | K080003 | BINAXNOW G6PD TEST | JBF | Substantially Equivalent | Binax, Inc. | accessdata.fda.gov |
| June 13, 2007 | DEN070006 | BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX | OAX | Unknown | Inverness Medical Professional Diagnostics-Binax | accessdata.fda.gov |
| March 15, 2007 | K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | MJH | Substantially Equivalent | Inverness Medical Professional Diagnostics | accessdata.fda.gov |
| October 21, 2003 | K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 | GQG | Substantially Equivalent | Binax, Inc. | accessdata.fda.gov |
| November 30, 2001 | K012521 | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST | GTZ | Substantially Equivalent | Binax, Inc. | accessdata.fda.gov |
| March 22, 1996 | K960712 | BINAX STREP A TEST | GTZ | Substantially Equivalent | Binax, Inc. | accessdata.fda.gov |
| September 20, 1994 | K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA | MJH | Substantially Equivalent | Binax, Inc. | accessdata.fda.gov |
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Updated February 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.