Product code CKG
- Device name
- Radioimmunoassay, Acth
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1025
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223867 | IDS ACTH II | Immunodiagnostic Systems Limited | 2023-08-18 |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | Tosoh Bioscience, Inc. | 2011-12-01 |
| K060585 | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH | Roche Diagnostics Corp. | 2006-05-03 |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | Scantibodies Laboratory, Inc. | 2005-05-20 |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | Scantibodies Laboratory, Inc. | 2002-06-03 |
| K002638 | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT | Future Diagnostics B.V. | 2001-01-17 |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | Sangui Biotech, Inc. | 1998-08-19 |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE | Nichols Institute Diagnostics | 1996-12-24 |
| K960491 | MICRO HAEMATOCRIT CENTRIFUGE | Hawksley & Sons , Ltd. | 1996-10-18 |
| K960066 | IMMULITE ACTH | Diagnostic Products Corp. | 1996-02-16 |
| K940271 | INCSTAR ACTH IRMA | Incstar Corp. | 1994-08-02 |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | Nichols Institute | 1993-07-27 |
| K915727 | ACTH IRMA KIT II MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | 1992-03-02 |
| K910178 | ACTH IRMA KIT MITSUBISHI YUKA | Science Regulatory Services Intl. | 1991-05-22 |
| K900147 | MODIFIED DSL-2300 ACTH RIA | Diagnostic Systems Laboratories, Inc. | 1990-03-01 |
| K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | Nichols Institute Diagnostics | 1988-08-30 |
| K860311 | ACTHK-PR RIA KIT | Compagnie Oris Industrie, S.A. | 1986-04-07 |
| K850053 | BACI 6 -ADRENOCORTICOTROOP HORMONE | Euro-Diagnostics BV | 1985-04-08 |
| K850882 | ACTH II BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1985-03-21 |
| K844181 | ACTH RIA | Syncor Intl. Corp. | 1984-11-27 |
| K842249 | ACTH NORMAL RANGE | Diagnostic Systems Laboratories, Inc. | 1984-08-15 |
| K833934 | ADRENOCORTICOTROPIC HORMONE TEST | Clinetics Corp. | 1984-04-04 |
| K840018 | DPC ACTH KIT | Diagnostic Products Corp. | 1984-03-23 |
| K833849 | ACTH RIA | Syncor Intl. Corp. | 1984-01-30 |
| K833471 | ADRENOCOR TICOTROPIC HORMONE RADIOIMM | Nichols Institute Diagnostics | 1984-01-11 |
| K831855 | HATCH KIT | Radioassay Systems Laboratories, Inc. | 1983-07-28 |
| K831826 | ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY | Damon Corp. | 1983-07-18 |
| K830893 | ACTH RIA SYSTEM-DSI 2300 | Diagnostic Systems Laboratories, Inc. | 1983-04-27 |
| K822115 | SERAGAN ACTH125 I-RIA KIT | Seragen Diagnostics, Inc. | 1982-10-18 |
| K811565 | ACTH RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-06-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870023847 | ACTH AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024806 | ACTH AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024844 | ACTH AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 04048474036473 | ACTH (Adrenocorticotropic Hormone) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 05060169696457 | IDS ACTH II | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2023-08-23 |
| 00083059070231 | ACTH [Adrenocorticotropic Hormone] ELISA | BIOMERICA, INC. | 2020-07-01 |
| 00850002253160 | Scantibodies Laboratory, Inc. | SCANTIBODIES LABORATORY, INC. | 2019-05-20 |
| 00840239036476 | ACTH (Adrenocorticotropic Hormone) ELISA | DRG International Inc | 2019-03-20 |
| B24221ACTHUE010 | Adrenocorticotropic Hormone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2017-08-03 |
| 04015630939893 | Elecsys ACTH | Roche Diagnostics GmbH | 2017-04-21 |
| 08305900070231 | ACTH [Adrenocorticotropic Hormone] ELISA | BIOMERICA, INC. | 2016-12-07 |
| 00817830022276 | ImmuChem hACTH Double Antibody 125I RIA Kit | MP BIOMEDICALS, LLC | 2016-10-20 |
| 00817830022283 | ImmuChem hACTH Double Antibody 125I RIA Kit | MP BIOMEDICALS, LLC | 2016-10-20 |
| 14560189212517 | ST AIA-PACK ACTH | TOSOH CORPORATION | 2016-09-24 |
| 04560189212541 | AIA-PACK ACTH Sample Diluting Solution | TOSOH CORPORATION | 2016-09-24 |
| 00630414953502 | IMMULITE®/IMMULITE® 1000 Systems ACT ACTH Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414960999 | IMMULITE® 2000 Systems ACT ACTH | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414963532 | IMMULITE®/IMMULITE® 1000 Systems ACT ACTH | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 04015630921522 | Elecsys ACTH Test System | Roche Diagnostics GmbH | 2016-09-20 |