FDA 510(k) Applications Submitted by Angela Drysdale
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190204 |
02/04/2019 |
ID NOW Influenza A & B 2 |
Alere Scarborough, Inc. |
| DEN180014 |
03/23/2018 |
WOUNDCHEK Bacterial Status |
Alere Scarborough, Inc. |
| K161364 |
05/17/2016 |
BinaxNOW G6PD Test |
ALERE SCARBOROUGH, INC. |
| K151464 |
06/01/2015 |
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
ALERE SCARBOROUGH, INC. |
| K141520 |
06/09/2014 |
ALERE I INFLUENZA A & B |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K191534 |
06/10/2019 |
ID NOW Influenza A & B 2 |
Abbott Diagnostics Scarborough, Inc. |
| K171792 |
06/16/2017 |
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
Alere Scarborough, Inc. |
| K151690 |
06/23/2015 |
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A |
ALERE SCARBOROUGH, INC. |
| K121905 |
06/29/2012 |
ALERE PBP2A TEST |
ALERE SCARBOROUGH, INC |
| K141757 |
06/30/2014 |
ALERE I STREP A |
ALERE SCARBOROUGH, INC |
| K181853 |
07/11/2018 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader |
Alere Scarborough, Inc. |
| K092223 |
07/23/2009 |
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K062109 |
07/24/2006 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K053126 |
11/07/2005 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K133411 |
11/07/2013 |
ALERE BINAXNOW INFLUENZA A & B CARD |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K133637 |
11/07/2013 |
ALERE INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K163266 |
11/21/2016 |
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument |
ALERE SCARBOROUGH, INC. |
| K123986 |
12/26/2012 |
ACTIM PROM |
ALERE SCARBOROUGH, INC |
| K173932 |
12/26/2017 |
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 |
Alere Scarborough, Inc. |
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