Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JKC — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
43 daysmedian FDA review time
139 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040181 | ACCESS DHEA-S REAGENT ASSAY | Beckman Coulter, Inc. | 2004-03-24 | 57 | 0 |
| K003174 | ELECSYS DHEA-S | Roche Diagnostics Corp. | 2001-01-17 | 99 | 0 |
| K973897 | DHEA-S | Kmi Diagnostics, Inc. | 1997-11-13 | 30 | 0 |
| K962895 | DSL DHEA-S-7 | Diagnostic Systems Laboratories, Inc. | 1996-09-10 | 47 | 0 |
| K955114 | DSL AACTIVE DHEA EIA KIT | Diagnostic Systems Laboratories, Inc. | 1996-02-23 | 106 | 0 |
| K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUN | Nichols Institute | 1995-05-15 | 105 | 0 |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Serono Diagnostics, Inc. | 1994-07-13 | 76 | 0 |
| K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | Diagnostic Systems Laboratories, Inc. | 1994-05-09 | 201 | 0 |
| K935806 | IMMULITE DHEA-S04 | Diagnostic Products Corp. | 1994-04-26 | 145 | 0 |
| K935469 | SYNELISA DHEA-SULFATE | Elias U.S.A., Inc. | 1994-03-22 | 139 | 0 |
| K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | Nichols Institute | 1993-07-27 | 117 | 0 |
| K903616 | DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) | Diagnostic Systems Laboratories, Inc. | 1990-09-10 | 33 | 0 |
| K891478 | DSL 7900 ACTIVE DHEA-S (DSL #7900) | Diagnostic Systems Laboratories, Inc. | 1989-04-26 | 41 | 0 |
| K872879 | DHEA-S RIA KIT | Endocrine Associates, Inc. | 1987-10-23 | 94 | 0 |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 1985-10-04 | 17 | 0 |
| K852847 | SOPHEIA DHEA-SO4 EIA KIT | Diagnostic Products Corp. | 1985-08-02 | 28 | 0 |
| K851239 | ACTIVE DHEA-SULFATE DSL3500 | Diagnostic Systems Laboratories, Inc. | 1985-04-25 | 29 | 0 |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Cambridge Medical Technology | 1984-09-28 | 11 | 0 |
| K842552 | COAT-A-COUNT DHEA-SO4 RIA KIT | Diagnostic Products Corp. | 1984-08-17 | 46 | 0 |
| K842606 | COAT-A-COUNT DHEA RIA KIT | Diagnostic Products Corp. | 1984-08-17 | 43 | 0 |
| K842555 | DHEA-S DIRECT RIA KIT | Biotecx Laboratories, Inc. | 1984-08-07 | 36 | 0 |
| K832154 | DHEA-SULFATE I RIA KIT | Diagnostic Systems Laboratories, Inc. | 1983-08-16 | 42 | 0 |
| K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE | Wien Laboratories, Inc. | 1982-11-29 | 34 | 0 |
| K822140 | IMMUCHEM COVALENT-COAT | Immuchem Corp. | 1982-08-05 | 16 | 0 |
| K821145 | I-DHEA-SULFATE RIA KIT 125 | Nuclear Medical Systems, Inc. | 1982-05-14 | 23 | 0 |
| K811906 | DHEA-SULFATE DIRECT RIA KIT(125I) | Immunalysis Corporation | 1981-07-23 | 22 | 0 |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | Radioassay Systems Laboratories, Inc. | 1980-10-23 | 43 | 0 |
| K792041 | DHEA-SULFATE TEST SET | Wien Laboratories, Inc. | 1979-10-30 | 18 | 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