# Abbott Diagnostics Scarborough, Inc.

- Location (FDA's records): Scarborough, ME
- FDA decisions: 8 (1996–2026): 7 510(k) clearances and 1 original PMA approval
- Product codes: OCC (3), QVF (1), QWR (1), OZE (1), QYT (1), NAH (1)
- 510(k) review time since 2016: median 61 days, against 134 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alere Scarborough, Inc.: 4 (https://510kreport.com/company/alere-scarborough)
- Quidel Corp.: 2 (https://510kreport.com/company/quidel)
- Nano-Ditech Corporation: 1 (https://510kreport.com/company/nano-ditech)

## Firms that cite its devices most
- Roche Molecular Systems, Inc.: 1 (https://510kreport.com/company/roche-molecular-systems)

## Its most-cited devices
- K221925: ID Now Covid-19 2.0 (2023), cited by 2
- K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (2022), cited by 2
- K232775: ID NOW Influenza A & B 2 (2023), cited by 1

## Recent decisions
- K262747: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 (Aug 31, 2026)
- K250273: BinaxNOW COVID-19 Ag Card (Jun 13, 2025)
- K243518: BinaxNOW™ COVID-19 Antigen Self Test (Feb 11, 2025)
- K232775: ID NOW Influenza A & B 2 (Oct 10, 2023)
- K221925: ID Now Covid-19 2.0 (Aug 10, 2023)
- K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (Jun 24, 2022)
- K191534: ID NOW Influenza A & B 2 (Jul 11, 2019)
- P940035: NMP22 BladderChek Test (Jul 2, 1996)

Source page: https://510kreport.com/company/abbott-diagnostics-scarborough