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Abbott Diagnostics Scarborough, Inc.

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

Total Devices7
Categories6
Latest FDA decision2025-06-13
TypeNumberDevice NameCodeDateActions
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
PMA P940035 System, test, tumor marker, for detection of bladder cancerNAH2022-07-12 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
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