Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIZ · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
99 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963002 | ACTIVE ANDROSTENEDIONE EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-16 | 14 | 0 |
| K954755 | COAT-A-COUNT DIRECT ANDROSTENEDIONE | Diagnostic Products Corp. | 1995-11-29 | 44 | 1 |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | Diagnostic Systems Laboratories, Inc. | 1994-01-10 | 98 | 0 |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Immuchem Corp. | 1986-03-14 | 28 | 0 |
| K854673 | DSL ANDROSTENEDIONE RIA (DSL # 4200) | Diagnostic Systems Laboratories, Inc. | 1986-01-22 | 62 | 0 |
| K854650 | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) | Diagnostic Systems Laboratories, Inc. | 1985-12-13 | 24 | 2 |
| K844398 | COAT-A-COUNT ANDROSTENEDIONE RIA KIT | Diagnostic Products Corp. | 1984-12-10 | 27 | 0 |
| K842960 | ANDROSTENEDIONE BY RIA | Radioassay Systems Laboratories, Inc. | 1984-09-27 | 62 | 0 |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Wien Laboratories, Inc. | 1983-09-12 | 49 | 0 |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Diagnostics Biochem Canada, Inc. | 1980-10-31 | 99 | 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