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

Not Cleared Dec 02, 2019

WOUNDCHEK Bacterial Status

DEN180014 · QFA

Microbiology · 619d

Cleared Mar 18, 2019

ID NOW Influenza A & B 2

K190204 · OZE

Microbiology · 42d

Cleared Aug 08, 2018

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

K181853 · PSZ

Microbiology · 28d

Cleared May 02, 2018

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

K173653 · PGX

Microbiology · 155d

Cleared Jan 26, 2018

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

K173932 · OCC

Microbiology · 31d

Cleared Dec 13, 2017

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

K173502 · PSZ

Microbiology · 30d

Cleared Sep 29, 2017

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

K171792 · OCC

Microbiology · 105d

Cleared Apr 10, 2017

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

K162642 · PSZ

Microbiology · 200d

Cleared Dec 21, 2016

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

K163266 · OCC

Microbiology · 30d

Cleared Aug 18, 2016

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

K161375 · OCC

Microbiology · 92d

Cleared Jul 28, 2015

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

K151464 · OCC

Microbiology · 57d

Cleared Jul 16, 2015

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

K151690 · OOI

Microbiology · 23d

Cleared Mar 31, 2015

ALERE I STREP A

K141757 · PGX

Microbiology · 274d

Cleared Sep 03, 2014

ALERE PBP2A SA/CONS CULTURE COLONY TEST

K133851 · MYI

Microbiology · 258d

Cleared Jul 26, 2012

ALERE PBP2A TEST

K121905 · MYI

Microbiology · 27d