Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott Diagnostics Scarborough, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
405 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 | 134 | 0 |
| K243518 | BinaxNOW™ COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | 2025-02-11 | 90 | 0 |
| K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 | 29 | 2 |
| K221925 | ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2023-08-10 | 405 | 2 |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A | Abbott Diagnostics Scarborough, Inc. | 2022-06-24 | 98 | 0 |
| K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 | 31 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda