Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guardian Scientific, Corp. · 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) |
|---|---|---|---|---|---|
| K972156 | QUIX RAPID E. COLI O157 STRIP TEST | Guardian Scientific, Corp. | 1997-10-16 | 129 | 0 |
| K954994 | TRUST | Guardian Scientific, Corp. | 1996-10-18 | 353 | 0 |
| K954995 | QUIX RAPID CHOLERA STRIP TEST | Guardian Scientific, Corp. | 1996-08-15 | 289 | 0 |
| K954993 | QUIX RAPID PREGNANCY STRIP TEST | Guardian Scientific, Corp. | 1995-12-13 | 43 | 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