Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Provalis Diagnostics , Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041635 | G5 I HBA1C TEST, G5 II HBA1C TEST | Provalis Diagnostics , Ltd. | 2004-08-16 | 61 | 4 |
| K011933 | GLYCOSAL II HBA 1C TEST | Provalis Diagnostics , Ltd. | 2001-11-02 | 135 | 0 |
| K001392 | GLYCOSAL HBA1C TEST | Provalis Diagnostics , Ltd. | 2000-08-21 | 110 | 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