FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
K Number: K173502
·
Decision Dec 13, 2017
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
17
Review Days
30
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Basic Information
- Device Name
- Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
- K Number
- K173502
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alere Scarborough, Inc.
- Date Received
- November 13, 2017
- Decision Date
- December 13, 2017
- Product Code
- PSZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | FDA class 2 | Microbiology |
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Other Clearances by Alere Scarborough, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN180014 | WOUNDCHEK Bacterial Status | Dec 2, 2019 | Unknown |
| K190204 | ID NOW Influenza A & B 2 | Mar 18, 2019 | Substantially Equivalent |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Aug 8, 2018 | Substantially Equivalent |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | May 2, 2018 | Substantially Equivalent |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Jan 26, 2018 | Substantially Equivalent |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Sep 29, 2017 | Substantially Equivalent |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Apr 10, 2017 | Substantially Equivalent |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | Dec 21, 2016 | Substantially Equivalent |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Aug 18, 2016 | Substantially Equivalent |
| K161364 | BinaxNOW G6PD Test | Jun 17, 2016 | Substantially Equivalent |