Panels › Clinical Chemistry › Product code JKR · Class 2
Radioimmunoassay, Calcitonin
Regulation 862.1140
1510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JKR
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 4 | 0 |
| Nichols Institute Diagnostics | 3 | 0 |
| Diagnostic Products Corp. | 2 | 0 |
| Roche Diagnostics | 2 | 0 |
| Scantibodies Laboratory, Inc. | 2 | 0 |
| Axis-Shield Diagnostics Limited | 1 | 0 |
| Biomerica | 0 | 1 |
| Cambridge Nuclear Radiopharmaceutical | 1 | 0 |
| Cis-Us, Inc. | 1 | 0 |
| Endocrine Associates, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2026 | K252431 | Elecsys Calcitonin Roche Diagnostics GmbH, DE | JKR |
| Dec 21, 2018 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay Axis-Shield Diagnostics Limited, GB | JKR |
| Dec 4, 2013 | K132828 | ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics | JKR |
| Aug 30, 2006 | K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) Scantibodies Laboratory, Inc. | JKR |
| Dec 9, 2002 | K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL Diagnostic Products Corp. | JKR |
| May 11, 1999 | K990073 | CALCITONIN Kmi Diagnostics, Inc. | JKR |
| Sep 3, 1998 | K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT Sangui Biotech, Inc. | JKR |
| May 21, 1997 | K964635 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT Nichols Institute Diagnostics | JKR |
| May 6, 1996 | K961043 | SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) Scantibodies Laboratory, Inc. | JKR |
| Nov 20, 1995 | K945961 | CALCITONIN IMMUNOASSAY KIT Nichols Institute Diagnostics | JKR |
| Sep 5, 1995 | K951708 | ELSA-HCT Cis-Us, Inc. | JKR |
| Jan 15, 1992 | K914429 | DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) Diagnostic Systems Laboratories, Inc. | JKR |
| Jul 18, 1991 | K912536 | CALCITONIN KIT MITSUBISHI YUKA Mitsubishi Yuka America, Inc. | JKR |
| Feb 2, 1988 | K874087 | MODIFIED CALCITONIN RIA KIT DSL #1200 Diagnostic Systems Laboratories, Inc. | JKR |
| Aug 13, 1987 | K872880 | CALCITONIN RIA KIT Endocrine Associates, Inc. | JKR |
| Jun 25, 1986 | K861274 | DOUBLE ANTIBODY CALCITONIN RIA KIT Diagnostic Products Corp. | JKR |
| Nov 22, 1985 | K854240 | CALCITONIN RIA KIT Diagnostic Systems Laboratories, Inc. | JKR |
| Sep 5, 1984 | K842907 | CALCITONIN RADIOIMMUNOASSAY KIT Nichols Institute Diagnostics | JKR |
| Jun 22, 1982 | K821675 | CALCITONIN RIA TEST KIT, DLS 1200 Diagnostic Systems Laboratories, Inc. | JKR |
| Jan 10, 1979 | K781909 | CALCITONIN 125 Cambridge Nuclear Radiopharmaceutical | JKR |
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