Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Assure Tech. Co., 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) |
|---|---|---|---|---|---|
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, A | Assure Tech. Co., Ltd. | 2016-02-24 | 153 | 0 |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, | Assure Tech. Co., Ltd. | 2015-10-05 | 75 | 0 |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, A | Assure Tech. Co., Ltd. | 2015-06-04 | 29 | 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