Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument— 510(k) K163266
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K163266 for Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument, Substantially Equivalent on 2016-12-21. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Product code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
Recent devices under product code OCC
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- K190204 — ID NOW Influenza A & B 2
- K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader
- K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
- K173932 — Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.