FDA Product Code
FDA Product Code JKR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1140
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026-04-24 | Traditional | PDF ↗ |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018-12-21 | Traditional | PDF ↗ |
| K132828 | ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 | Roche Diagnostics | 2013-12-04 | Traditional | PDF ↗ |
| K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | Scantibodies Laboratory, Inc. | 2006-08-30 | Traditional | PDF ↗ |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Diagnostic Products Corp. | 2002-12-09 | Traditional | PDF ↗ |
| K990073 | CALCITONIN | Kmi Diagnostics, Inc. | 1999-05-11 | Traditional | PDF ↗ |
| K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | Sangui Biotech, Inc. | 1998-09-03 | Traditional | PDF ↗ |
| K964635 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT | Nichols Institute Diagnostics | 1997-05-21 | Traditional | PDF ↗ |
| K961043 | SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) | Scantibodies Laboratory, Inc. | 1996-05-06 | Traditional | PDF ↗ |
| K945961 | CALCITONIN IMMUNOASSAY KIT | Nichols Institute Diagnostics | 1995-11-20 | Traditional | PDF ↗ |
| K951708 | ELSA-HCT | Cis-Us, Inc. | 1995-09-05 | Traditional | PDF ↗ |
| K914429 | DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) | Diagnostic Systems Laboratories, Inc. | 1992-01-15 | Traditional | PDF ↗ |
| K912536 | CALCITONIN KIT MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | 1991-07-18 | Traditional | PDF ↗ |
| K874087 | MODIFIED CALCITONIN RIA KIT DSL #1200 | Diagnostic Systems Laboratories, Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K872880 | CALCITONIN RIA KIT | Endocrine Associates, Inc. | 1987-08-13 | Traditional | PDF ↗ |
| K861274 | DOUBLE ANTIBODY CALCITONIN RIA KIT | Diagnostic Products Corp. | 1986-06-25 | Traditional | PDF ↗ |
| K854240 | CALCITONIN RIA KIT | Diagnostic Systems Laboratories, Inc. | 1985-11-22 | Traditional | PDF ↗ |
| K842907 | CALCITONIN RADIOIMMUNOASSAY KIT | Nichols Institute Diagnostics | 1984-09-05 | Traditional | PDF ↗ |
| K821675 | CALCITONIN RIA TEST KIT, DLS 1200 | Diagnostic Systems Laboratories, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K781909 | CALCITONIN 125 | Cambridge Nuclear Radiopharmaceutical | 1979-01-10 | Traditional | PDF ↗ |
Product code JKR · Class II · Clinical Chemistry. Data: openFDA.