Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quantase , Ltd. — 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) |
|---|---|---|---|---|---|
| K000754 | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 2000-06-19 | 103 | 1 |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Quantase , Ltd. | 1999-06-21 | 115 | 1 |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 1999-06-21 | 112 | 1 |
| K984463 | QUANTASE PHE/GAL SCREENING ASSAY | Quantase , Ltd. | 1999-02-16 | 62 | 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