Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oxford Laboratories, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
32 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K780912 | ADJUSTABLE DISPENSOR | Oxford Laboratories, Inc. | 1978-06-28 | 23 | 0 |
| K760146 | SERUM, IGA GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-20 | 21 | 0 |
| K760079 | REAGENT, THYROXINE T4 (#210) | Oxford Laboratories, Inc. | 1976-07-20 | 32 | 0 |
| K760147 | SERUM, IGM ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-20 | 21 | 0 |
| K760144 | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-20 | 21 | 0 |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Oxford Laboratories, Inc. | 1976-07-20 | 21 | 0 |
| K760148 | SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN | Oxford Laboratories, Inc. | 1976-07-20 | 21 | 0 |
| K760078 | REAGENT, RIA TRIIODOTHYRONINE T3 (#200) | Oxford Laboratories, Inc. | 1976-07-20 | 32 | 0 |
| K760145 | SERUM, IGG GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-19 | 20 | 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