Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Technia Diagnostics , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
85 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861978 | AUTOFLUOR V | Technia Diagnostics , Ltd. | 1986-06-10 | 20 | 0 |
| K801843 | T3(125) RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | 1980-09-16 | 46 | 0 |
| K801202 | DIGOXIN RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | 1980-06-20 | 32 | 0 |
| K801203 | CORTISOL RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | 1980-06-09 | 21 | 0 |
| K791361 | T3 UPTAKE RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | 1979-08-16 | 27 | 0 |
| K790919 | HPL RIA KIT | Technia Diagnostics , Ltd. | 1979-06-28 | 45 | 0 |
| K790495 | THYROXINE RIA KIT | Technia Diagnostics , Ltd. | 1979-05-03 | 51 | 0 |
| K782024 | RIA KIT, VITAMIN B12 | Technia Diagnostics , Ltd. | 1979-02-28 | 85 | 0 |
| K782025 | GENTAMICIN FLUROIMMUNASSAY KIT | Technia Diagnostics , Ltd. | 1979-01-26 | 52 | 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