Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Abbott Diagnostics Scarborough, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0OCC2026-08-31 View
510(k) K250273 BinaxNOW COVID-19 Ag CardQVF2025-06-13 View
510(k) K243518 BinaxNOW™ COVID-19 Antigen Self TestQYT2025-02-11 View
510(k) K232775 ID NOW Influenza A & B 2OCC2023-10-10 View
510(k) K221925 ID NOW COVID-19 2.0QWR2023-08-10 View
510(k) K220801 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2OZE2022-06-24 View
510(k) K191534 ID NOW Influenza A & B 2OCC2019-07-11 View
↑