FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
K Number: K151464
·
Decision Jul 28, 2015
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
17
Review Days
57
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
- K Number
- K151464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alere Scarborough, Inc.
- Date Received
- June 1, 2015
- Decision Date
- July 28, 2015
- Product Code
- OCC
- 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 |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCC), ordered by most recent decision date.
BioCode® Respiratory Pathogen Panel (RPP)
FDA 510(k)
FDA Class 2
·Microbiology
NxTAG® Respiratory Pathogen Panel
FDA 510(k)
FDA Class 2
·Microbiology
ID NOW Influenza A & B 2
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion AdV/hMPV/RV Assay
FDA 510(k)
FDA Class 2
·Microbiology
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
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 |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Dec 13, 2017 | 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 |