FDA Product Code
FDA Product Code JKC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1245
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040181 | ACCESS DHEA-S REAGENT ASSAY | Beckman Coulter, Inc. | 2004-03-24 | Abbreviated | PDF ↗ |
| K003174 | ELECSYS DHEA-S | Roche Diagnostics Corp. | 2001-01-17 | Traditional | PDF ↗ |
| K973897 | DHEA-S | Kmi Diagnostics, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K962895 | DSL DHEA-S-7 | Diagnostic Systems Laboratories, Inc. | 1996-09-10 | Traditional | PDF ↗ |
| K955114 | DSL AACTIVE DHEA EIA KIT | Diagnostic Systems Laboratories, Inc. | 1996-02-23 | Traditional | PDF ↗ |
| K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | Nichols Institute | 1995-05-15 | Traditional | PDF ↗ |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Serono Diagnostics, Inc. | 1994-07-13 | Traditional | PDF ↗ |
| K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | Diagnostic Systems Laboratories, Inc. | 1994-05-09 | Traditional | PDF ↗ |
| K935806 | IMMULITE DHEA-S04 | Diagnostic Products Corp. | 1994-04-26 | Traditional | PDF ↗ |
| K935469 | SYNELISA DHEA-SULFATE | Elias U.S.A., Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | Nichols Institute | 1993-07-27 | Traditional | PDF ↗ |
| K903616 | DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) | Diagnostic Systems Laboratories, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K891478 | DSL 7900 ACTIVE DHEA-S (DSL #7900) | Diagnostic Systems Laboratories, Inc. | 1989-04-26 | Traditional | PDF ↗ |
| K872879 | DHEA-S RIA KIT | Endocrine Associates, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K852847 | SOPHEIA DHEA-SO4 EIA KIT | Diagnostic Products Corp. | 1985-08-02 | Traditional | PDF ↗ |
| K851239 | ACTIVE DHEA-SULFATE DSL3500 | Diagnostic Systems Laboratories, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Cambridge Medical Technology | 1984-09-28 | Traditional | PDF ↗ |
| K842606 | COAT-A-COUNT DHEA RIA KIT | Diagnostic Products Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K842552 | COAT-A-COUNT DHEA-SO4 RIA KIT | Diagnostic Products Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K842555 | DHEA-S DIRECT RIA KIT | Biotecx Laboratories, Inc. | 1984-08-07 | Traditional | PDF ↗ |
| K832154 | DHEA-SULFATE I RIA KIT | Diagnostic Systems Laboratories, Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE | Wien Laboratories, Inc. | 1982-11-29 | Traditional | PDF ↗ |
| K822140 | IMMUCHEM COVALENT-COAT | Immuchem Corp. | 1982-08-05 | Traditional | PDF ↗ |
| K821145 | I-DHEA-SULFATE RIA KIT 125 | Nuclear Medical Systems, Inc. | 1982-05-14 | Traditional | PDF ↗ |
| K811906 | DHEA-SULFATE DIRECT RIA KIT(125I) | Immunalysis Corporation | 1981-07-23 | Traditional | PDF ↗ |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | Radioassay Systems Laboratories, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K792041 | DHEA-SULFATE TEST SET | Wien Laboratories, Inc. | 1979-10-30 | Traditional | PDF ↗ |
Product code JKC · Class I · Clinical Chemistry. Data: openFDA.