# Alere Scarborough, Inc.

- Location (FDA's records): Scarborough, ME
- FDA decisions: 17 (2012–2019): 16 510(k) clearances and 1 De Novo grant
- Product codes: OCC (5), PSZ (3), MYI (2), PGX (2), OAM (1), JBF (1), OOI (1), OZE (1), QFA (1)
- 510(k) review time since 2016: median 37 days, against 113 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 20 (11 its own); citations of its devices by later devices: 15 (11 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
- Quidel Corp.: 2 (https://510kreport.com/company/quidel)
- Binax, Inc.: 2 (https://510kreport.com/company/binax)
- Alere Scarborough, Inc D/B/A Binax, Inc.: 2 (https://510kreport.com/company/alere-scarborough-d-b-a-binax)
- Medix Biochemica: 1 (https://510kreport.com/company/medix-biochemica)
- Oxoid, Ltd.: 1 (https://510kreport.com/company/oxoid)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Firms that cite its devices most
- Abbott Diagnostics Scarborough, Inc.: 4 (https://510kreport.com/company/abbott-diagnostics-scarborough)

## Its most-cited devices
- K141757: Alere I Strep a (2015), cited by 2
- K171792: Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2017), cited by 2
- K173932: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (2018), cited by 2
- K163266: Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (2016), cited by 2
- K161375: Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (2016), cited by 1
- K151690: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (2015), cited by 1

## Recent decisions
- DEN180014: WOUNDCHEK Bacterial Status (Dec 2, 2019)
- K190204: ID NOW Influenza A & B 2 (Mar 18, 2019)
- K181853: Alere BinaxNOW Influenza A & B Card 2, Alere Reader (Aug 8, 2018)
- K173653: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (May 2, 2018)
- K173932: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (Jan 26, 2018)
- K173502: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (Dec 13, 2017)
- K171792: Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (Sep 29, 2017)
- K162642: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (Apr 10, 2017)

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