Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JWL · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831296 | POLYCHACO FIA-ABS TEST FOR SYPHILIS | Parasitic Disease Consultants | 1983-07-26 | 97 | 0 |
| K801959 | FTA-ABS TEST | Immuno-Diagnostic Products, Inc. | 1980-10-23 | 65 | 0 |
| K802276 | FTA-ABS BIOPAK | Bioware Products | 1980-10-23 | 35 | 0 |
| K801928 | LAB-TEK FTA-ABS KIT | Miles Laboratories, Inc. | 1980-08-20 | 8 | 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