Product code JKC
- Device name
- Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1245
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040181 | ACCESS DHEA-S REAGENT ASSAY | Beckman Coulter, Inc. | 2004-03-24 |
| K003174 | ELECSYS DHEA-S | Roche Diagnostics Corp. | 2001-01-17 |
| K973897 | DHEA-S | Kmi Diagnostics, Inc. | 1997-11-13 |
| K962895 | DSL DHEA-S-7 | Diagnostic Systems Laboratories, Inc. | 1996-09-10 |
| K955114 | DSL AACTIVE DHEA EIA KIT | Diagnostic Systems Laboratories, Inc. | 1996-02-23 |
| K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | Nichols Institute | 1995-05-15 |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Serono Diagnostics, Inc. | 1994-07-13 |
| K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | Diagnostic Systems Laboratories, Inc. | 1994-05-09 |
| K935806 | IMMULITE DHEA-S04 | Diagnostic Products Corp. | 1994-04-26 |
| K935469 | SYNELISA DHEA-SULFATE | Elias U.S.A., Inc. | 1994-03-22 |
| K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | Nichols Institute | 1993-07-27 |
| K903616 | DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) | Diagnostic Systems Laboratories, Inc. | 1990-09-10 |
| K891478 | DSL 7900 ACTIVE DHEA-S (DSL #7900) | Diagnostic Systems Laboratories, Inc. | 1989-04-26 |
| K872879 | DHEA-S RIA KIT | Endocrine Associates, Inc. | 1987-10-23 |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 1985-10-04 |
| K852847 | SOPHEIA DHEA-SO4 EIA KIT | Diagnostic Products Corp. | 1985-08-02 |
| K851239 | ACTIVE DHEA-SULFATE DSL3500 | Diagnostic Systems Laboratories, Inc. | 1985-04-25 |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Cambridge Medical Technology | 1984-09-28 |
| K842552 | COAT-A-COUNT DHEA-SO4 RIA KIT | Diagnostic Products Corp. | 1984-08-17 |
| K842606 | COAT-A-COUNT DHEA RIA KIT | Diagnostic Products Corp. | 1984-08-17 |
| K842555 | DHEA-S DIRECT RIA KIT | Biotecx Laboratories, Inc. | 1984-08-07 |
| K832154 | DHEA-SULFATE I RIA KIT | Diagnostic Systems Laboratories, Inc. | 1983-08-16 |
| K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE | Wien Laboratories, Inc. | 1982-11-29 |
| K822140 | IMMUCHEM COVALENT-COAT | Immuchem Corp. | 1982-08-05 |
| K821145 | I-DHEA-SULFATE RIA KIT 125 | Nuclear Medical Systems, Inc. | 1982-05-14 |
| K811906 | DHEA-SULFATE DIRECT RIA KIT(125I) | Immunalysis Corporation | 1981-07-23 |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | Radioassay Systems Laboratories, Inc. | 1980-10-23 |
| K792041 | DHEA-SULFATE TEST SET | Wien Laboratories, Inc. | 1979-10-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336232132 | Ionify Steroids 2 | Roche Diagnostics GmbH | 2025-12-11 |
| 04049325034754 | DHEA ELISA | IBL International GmbH | 2025-04-30 |
| 00630414652597 | Atellica IM DHEAS2 (REF) 500T | Siemens Healthcare Diagnostics Inc. | 2025-03-20 |
| 00630414321486 | Atellica IM DHEAS2 (REF) 500T | Siemens Healthcare Diagnostics Inc. | 2025-03-20 |
| 00630414632926 | Atellica IM DHEAS2 100T KIT | Siemens Healthcare Diagnostics Inc. | 2025-03-20 |
| 04048474015621 | DHEA-S ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 04048474053470 | DHEA-S | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474053463 | DHEA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474034158 | DHEA ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239053466 | DHEA | DRG International Inc | 2023-08-26 |
| 00840239053473 | DHEA-S | DRG International Inc | 2023-08-26 |
| 04048474046526 | DHEA-S | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-26 |
| 00840239034151 | DHEA ELISA | DRG International Inc | 2023-08-24 |
| 00840239015624 | DHEA-S ELISA | DRG International Inc | 2023-08-23 |
| 00817830023020 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-01 |
| 15099590211509 | DHEA-S-7 RIA | IMMUNOTECH s.r.o. | 2023-07-06 |
| 04049016140368 | Dehydroepiandrosterone Sulfate (DHEA-S) ELISA | EUROIMMUN Medizinische Labordiagnostika AG | 2022-12-08 |
| 04049016152170 | Dehydroepiandrosterone (DHEA) ELISA | EUROIMMUN Medizinische Labordiagnostika AG | 2022-12-08 |
| B261CANDH4900 | DBC Dehydroepiandrosterone (DHEA) ELISA | Diagnostics Biochem Canada Inc | 2022-11-10 |
| B261CANDHS4800 | DBC Dehydroepiandrosterone Sulfate (DHEAS) ELISA | Diagnostics Biochem Canada Inc | 2022-11-10 |
| 06925912718550 | iFlash-DHEA-S | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| B24220DHSHUE010 | DHEA-S ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2022-09-09 |
| B24211HEAHUE010 | Dehydroepiandrosterone (DHEA) ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2022-09-09 |
| 15099590201449 | Access DHEA-S Calibrators | Beckman Coulter, Inc. | 2021-09-23 |
| 15099590201432 | Access DHEA-S | Beckman Coulter, Inc. | 2021-09-23 |
| 14560189212562 | ST AIA-PACK DHEA-S | TOSOH CORPORATION | 2019-07-24 |
| 24560189212569 | ST AIA-PACK DHEA-S | TOSOH CORPORATION | 2019-07-24 |
| 14560189212593 | ST AIA-PACK DHEA-S Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 04560189212596 | ST AIA-PACK DHEA-S Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 04015630940387 | Elecsys DHEA-S | Roche Diagnostics GmbH | 2017-04-21 |