Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JGF · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
120 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981338 | LD-1 | Abbott Laboratories | 1998-05-18 | 35 | 0 |
| K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION | Em Diagnostic Systems, Inc. | 1993-02-05 | 120 | 0 |
| K914261 | ABBOTT QUICKSTART LD-1,#5A30 | Em Diagnostic Systems, Inc. | 1991-10-21 | 28 | 0 |
| K890996 | LD1 ISOENZYME REAGENT KIT | Trace Scientific , Ltd. | 1989-05-05 | 67 | 0 |
| K871240 | ABBOTT A-GENT LD-1 ISOZYME REAGENT | Abbott Laboratories | 1987-05-13 | 47 | 0 |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Alpkem Corp. | 1986-04-11 | 67 | 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