ID NOW Influenza A & B 2— 510(k) K232775
Substantially EquivalentAbbott Diagnostics Scarborough, Inc.
FDA 510(k) clearance K232775 for ID NOW Influenza A & B 2, Substantially Equivalent on 2023-10-10. Applicant: Abbott Diagnostics Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diagnostics 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
- Special
- Location
- Scarborough, ME, US
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More clearances from Abbott Diagnostics Scarborough, Inc.
view allAdverse 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 K232775
K-number listed on FDA's recall record- Z-1572-2025 — Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
- Z-1575-2025 — Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232775.
Data sourced from openFDA. This site is unofficial and independent of the FDA.