Alere Scarborough, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN180014 | WOUNDCHEK Bacterial Status | December 2, 2019 |
| K190204 | ID NOW Influenza A & B 2 | March 18, 2019 |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | August 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 | January 26, 2018 |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control S | December 13, 2017 |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | September 29, 2017 |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control S | April 10, 2017 |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | December 21, 2016 |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | August 18, 2016 |
| K161364 | BinaxNOW G6PD Test | June 17, 2016 |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | July 28, 2015 |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | July 16, 2015 |
| K141757 | ALERE I STREP A | March 31, 2015 |
| K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST | September 3, 2014 |
| K123986 | ACTIM PROM | January 9, 2014 |
| K121905 | ALERE PBP2A TEST | July 26, 2012 |