Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iso-Tex Diagnostics — 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) |
|---|---|---|---|---|---|
| K851389 | APO B RIA KIT | Iso-Tex Diagnostics | 1985-07-10 | 92 | 0 |
| K840105 | APO A-I RIA KIT-HUMAN PLASMA APOLIP- | Iso-Tex Diagnostics | 1984-01-10 | 0 | 0 |
| K782081 | RIA SYSTEM, PARATHYROID HORMONE | Iso-Tex Diagnostics | 1979-03-21 | 98 | 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