Alere Scarborough, Inc. - FDA 510(k) Cleared Devices
17
Total
16
Cleared
1
Denied
Alere Scarborough, Inc. has 16 FDA 510(k) cleared microbiology devices. Based in Scarborough, US.
Historical record: 16 cleared submissions from 2012 to 2019.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Alere Scarborough, Inc.
17 devices
Not Cleared
Dec 02, 2019
WOUNDCHEK Bacterial Status
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
Jun 17, 2016
BinaxNOW G6PD Test
Hematology
31d
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
Cleared
Mar 31, 2015
ALERE I STREP A
Microbiology
274d
Cleared
Sep 03, 2014
ALERE PBP2A SA/CONS CULTURE COLONY TEST
Microbiology
258d
Cleared
Jan 09, 2014
ACTIM PROM
Chemistry
379d
Cleared
Jul 26, 2012
ALERE PBP2A TEST
Microbiology
27d