Alere i Instrument, Alere i Influenza A & B, Alere i Strep A— 510(k) K151690
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K151690 for Alere i Instrument, Alere i Influenza A & B, Alere i Strep A, Substantially Equivalent on 2015-07-16. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code OOI
- Device class
- Class 2
- Regulation
- 21 CFR 862.2570
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
Recent devices under product code OOI
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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 OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
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.