Medical Device Manufacturer · US , Scarborough , ME

Alere Scarborough, Inc. - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2012

Recent clearances: ID NOW Influenza A & B 2, Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

17

Total

16

Cleared

1

Denied

FDA 510(k) Regulatory Record - Alere Scarborough, Inc. Microbiology ✕

15 devices

1-12 of 15

Not Cleared Dec 02, 2019

WOUNDCHEK Bacterial Status

DEN180014 · QFA

Microbiology · 619d

Cleared Mar 18, 2019

ID NOW Influenza A & B 2

Microbiology · 42d

Cleared Aug 08, 2018

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

Microbiology · 28d

Cleared May 02, 2018

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

Microbiology · 155d

Cleared Jan 26, 2018

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

Microbiology · 31d

Cleared Dec 13, 2017

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza...

Microbiology · 30d

Cleared Sep 29, 2017

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B...

Microbiology · 105d

Cleared Apr 10, 2017

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza...

Microbiology · 200d

Cleared Dec 21, 2016

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i...

Microbiology · 30d

Cleared Aug 18, 2016

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

Microbiology · 92d

Cleared Jul 28, 2015

Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control...

Microbiology · 57d

Cleared Jul 16, 2015

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

Microbiology · 23d