FDA 510(k) Applications Submitted by ALERE SCARBOROUGH, INC.
| 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. |
| 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. |
| K181853 |
07/11/2018 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader |
Alere Scarborough, Inc. |
| K163266 |
11/21/2016 |
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument |
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. |
| K161375 |
05/18/2016 |
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit |
ALERE SCARBOROUGH, INC. |
| K173502 |
11/13/2017 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
Alere Scarborough, Inc. |
| K173653 |
11/28/2017 |
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit |
Alere Scarborough, Inc. |
| K162642 |
09/22/2016 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
ALERE SCARBOROUGH, INC. |
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