Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LES · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
20 daysmedian FDA review time
38 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K865102 | IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS | Sclavo, Inc. | 1987-01-13 | 20 | 0 |
| K844990 | SYVA ADVANCE EMIT PHENYTOIN ASSAY | Syva Co. | 1985-01-23 | 28 | 0 |
| K831154 | STRATUS PHENYTOIN FLUOROMETRIC ENZYME | American Dade | 1983-05-16 | 38 | 0 |
| K820187 | SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY | Syva Co. | 1982-02-12 | 18 | 0 |
| K813538 | PHENYTOIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1981-12-31 | 10 | 0 |
| K811025 | AMES TDA TM PHENYTOIN TEST | Miles Laboratories, Inc. | 1981-04-29 | 13 | 0 |
| K801736 | AMES TDA TM PHENYTOIN TEST | Miles Laboratories, Inc. | 1980-08-20 | 26 | 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