Product code CIZ
- Device name
- Radioimmunoassay, Androstenedione
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1075
- 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 |
|---|---|---|---|
| K963002 | ACTIVE ANDROSTENEDIONE EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-16 |
| K954755 | COAT-A-COUNT DIRECT ANDROSTENEDIONE | Diagnostic Products Corp. | 1995-11-29 |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | Diagnostic Systems Laboratories, Inc. | 1994-01-10 |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Immuchem Corp. | 1986-03-14 |
| K854673 | DSL ANDROSTENEDIONE RIA (DSL # 4200) | Diagnostic Systems Laboratories, Inc. | 1986-01-22 |
| K854650 | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) | Diagnostic Systems Laboratories, Inc. | 1985-12-13 |
| K844398 | COAT-A-COUNT ANDROSTENEDIONE RIA KIT | Diagnostic Products Corp. | 1984-12-10 |
| K842960 | ANDROSTENEDIONE BY RIA | Radioassay Systems Laboratories, Inc. | 1984-09-27 |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Wien Laboratories, Inc. | 1983-09-12 |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Diagnostics Biochem Canada, Inc. | 1980-10-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00894175000824 | AccuDiag™ ANST (Androstenedione) ELISA | Diagnostic Automation, Inc. | 2026-01-27 |
| 00816870023816 | ANST AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023823 | ANST AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024707 | ANST AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024714 | ANST AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 04048474053395 | Androstenedione | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474032659 | Androstenedione ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239053398 | Androstenedione | DRG International Inc | 2023-08-26 |
| 00840239032652 | Androstenedione ELISA | DRG International Inc | 2023-08-24 |
| 05060169691261 | IDS Androstenedione | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2023-06-27 |
| 04049016138365 | Androstenedione ELISA | EUROIMMUN Medizinische Labordiagnostika AG | 2022-12-08 |
| B261CANAD2080 | DBC Androstenedione ELISA | Diagnostics Biochem Canada Inc | 2022-11-15 |
| 06925912718055 | iFlash-Androstenedione | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 00404847432657 | Androstenedione ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847450507 | Androstenedione ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847453393 | Androstenedione | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 05400569000346 | ANDROSTENEDIONE-RIA-CT | Diasource Immunoassays S.A. SA | 2020-10-05 |
| B24211ANRHUE010 | Androstenedione ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| 00630414961026 | IMMULITE® 2000 Systems AND Androstenedione | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414963570 | IMMULITE®/IMMULITE® 1000 Systems AND Androstenedione | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 05400569000865 | Androstenedione-ELISA | Diasource Immunoassays S.A. SA | 2020-09-14 |
| 07613336169292 | Elecsys Androstenedione | Roche Diagnostics GmbH | 2020-03-05 |
| 07613336169308 | Elecsys Androstenedione | Roche Diagnostics GmbH | 2020-03-05 |
| 00630414285566 | Atellica IM Androstenedione kit | Siemens Healthcare Diagnostics Inc. | 2019-12-04 |
| 00630414603445 | ADVIA Centaur Androstenedione kit | Siemens Healthcare Diagnostics Inc. | 2019-10-25 |