Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit— 510(k) K161375
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K161375 for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit, Substantially Equivalent on 2016-08-18. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
Recent devices under product code OCC
view allMore clearances from Alere Scarborough, Inc.
view all- DEN180014 — WOUNDCHEK Bacterial Status
- 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 →
Recalls naming K161375
K-number listed on FDA's recall record- Z-1573-2025 — Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
- Z-1576-2025 — Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161375.
Data sourced from openFDA. This site is unofficial and independent of the FDA.