Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teco Diagnostics, Inc. — 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) |
|---|---|---|---|---|---|
| K161527 | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | 2017-07-21 | 414 | 0 |
| K170200 | Carbon Dioxide Reagent Set | Teco Diagnostics, Inc. | 2017-06-01 | 129 | 0 |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-07-22 | 163 | 0 |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-03-07 | 160 | 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