Product code JKR
- Device name
- Radioimmunoassay, Calcitonin
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1140
- 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 |
|---|---|---|---|
| K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026-04-24 |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018-12-21 |
| K132828 | ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 | Roche Diagnostics | 2013-12-04 |
| K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | Scantibodies Laboratory, Inc. | 2006-08-30 |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Diagnostic Products Corp. | 2002-12-09 |
| K990073 | CALCITONIN | Kmi Diagnostics, Inc. | 1999-05-11 |
| K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | Sangui Biotech, Inc. | 1998-09-03 |
| K964635 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT | Nichols Institute Diagnostics | 1997-05-21 |
| K961043 | SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) | Scantibodies Laboratory, Inc. | 1996-05-06 |
| K945961 | CALCITONIN IMMUNOASSAY KIT | Nichols Institute Diagnostics | 1995-11-20 |
| K951708 | ELSA-HCT | Cis-Us, Inc. | 1995-09-05 |
| K914429 | DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) | Diagnostic Systems Laboratories, Inc. | 1992-01-15 |
| K912536 | CALCITONIN KIT MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | 1991-07-18 |
| K874087 | MODIFIED CALCITONIN RIA KIT DSL #1200 | Diagnostic Systems Laboratories, Inc. | 1988-02-02 |
| K872880 | CALCITONIN RIA KIT | Endocrine Associates, Inc. | 1987-08-13 |
| K861274 | DOUBLE ANTIBODY CALCITONIN RIA KIT | Diagnostic Products Corp. | 1986-06-25 |
| K854240 | CALCITONIN RIA KIT | Diagnostic Systems Laboratories, Inc. | 1985-11-22 |
| K842907 | CALCITONIN RADIOIMMUNOASSAY KIT | Nichols Institute Diagnostics | 1984-09-05 |
| K821675 | CALCITONIN RIA TEST KIT, DLS 1200 | Diagnostic Systems Laboratories, Inc. | 1982-06-22 |
| K781909 | CALCITONIN 125 | Cambridge Nuclear Radiopharmaceutical | 1979-01-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870023694 | Calcitonin AccuLite CLIA Test System -192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023700 | Calcitonin AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023717 | Calcitonin AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023724 | Calcitonin AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 04048474036480 | Calcitonin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 00083059070248 | Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2020-07-01 |
| 00630414284736 | ADVIA Centaur Calcitonin | Siemens Healthcare Diagnostics Inc. | 2019-07-05 |
| 00630414284743 | Atellica IM Calcitonin | Siemens Healthcare Diagnostics Inc. | 2019-07-05 |
| 00840239036483 | Calcitonin ELISA | DRG International Inc | 2019-06-10 |
| 00850002253153 | Scantibodies Laboratory, Inc. | SCANTIBODIES LABORATORY, INC. | 2019-05-20 |
| B24221CALHUE010 | Calcitonin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2017-08-03 |
| 04015630940158 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2017-04-21 |
| 08305900070248 | Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2016-12-07 |
| 00630414953120 | IMMULITE® Systems CONTROL Calcitonin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414953618 | IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961156 | IMMULITE® 2000 Systems CAL Calcitonin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414963730 | IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 04015630934799 | Elecsys Calcitonin Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 30014613333937 | MicroVue | QUIDEL CORPORATION | 2016-09-15 |