Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JNM · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992188 | NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECE | Nichols Institute Diagnostics | 1999-12-06 | 160 | 0 |
| K981208 | TFR | Ramco Laboratories, Inc. | 1998-10-21 | 202 | 0 |
| K970718 | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA | R&D Systems, Inc. | 1997-05-27 | 90 | 1 |
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