Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Dna Technologies, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080467 | BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN | Applied Dna Technologies, Inc. | 2008-11-25 | 278 | 0 |
| K071030 | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TES | Applied Dna Technologies, Inc. | 2007-06-29 | 79 | 0 |
| K070921 | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08 | Applied Dna Technologies, Inc. | 2007-06-29 | 88 | 0 |
| K061005 | ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS | Applied Dna Technologies, Inc. | 2006-10-04 | 176 | 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