JKR — Radioimmunoassay, Calcitonin Class II
FDA product code JKR covers "Radioimmunoassay, Calcitonin", a Class II medical device regulated under 21 CFR 862.1140. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JKR
- Device Class
- Class II
- Regulation Number
- 862.1140
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252431 | roche diagnostics | Elecsys Calcitonin | April 24, 2026 |
| K182012 | axis-shield diagnostics limited | ADVIA Centaur Calcitonin (CALCT) assay | December 21, 2018 |
| K132828 | roche diagnostics | ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA | December 4, 2013 |
| K060578 | scantibodies laboratory | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | August 30, 2006 |
| K023304 | diagnostic products | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE | December 9, 2002 |
| K990073 | kmi diagnostics | CALCITONIN | May 11, 1999 |
| K982491 | sangui biotech | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | September 3, 1998 |
| K964635 | nichols institute diagnostics | NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT | May 21, 1997 |
| K961043 | scantibodies laboratory | SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) | May 6, 1996 |
| K945961 | nichols institute diagnostics | CALCITONIN IMMUNOASSAY KIT | November 20, 1995 |
| K951708 | cis-us | ELSA-HCT | September 5, 1995 |
| K914429 | diagnostic systems laboratories | DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) | January 15, 1992 |
| K912536 | mitsubishi yuka america | CALCITONIN KIT MITSUBISHI YUKA | July 18, 1991 |
| K874087 | diagnostic systems laboratories | MODIFIED CALCITONIN RIA KIT DSL #1200 | February 2, 1988 |
| K872880 | endocrine associates | CALCITONIN RIA KIT | August 13, 1987 |
| K861274 | diagnostic products | DOUBLE ANTIBODY CALCITONIN RIA KIT | June 25, 1986 |
| K854240 | diagnostic systems laboratories | CALCITONIN RIA KIT | November 22, 1985 |
| K842907 | nichols institute diagnostics | CALCITONIN RADIOIMMUNOASSAY KIT | September 5, 1984 |
| K821675 | diagnostic systems laboratories | CALCITONIN RIA TEST KIT, DLS 1200 | June 22, 1982 |
| K781909 | cambridge nuclear radiopharmaceutical | CALCITONIN 125 | January 10, 1979 |