Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LAG · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073078 | RAPID TOX CUP | American Bio Medica Corp. | 2008-05-30 | 212 | 0 |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO | Princeton BioMeditech Corp. | 2007-11-26 | 452 | 0 |
| K990786 | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/ | Princeton BioMeditech Corp. | 1999-03-26 | 16 | 0 |
| K983501 | ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/ | Princeton BioMeditech Corp. | 1998-12-18 | 73 | 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