510(k) K060578
- Device
- CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- Applicant
- SCANTIBODIES LABORATORY, INC.
- 510(k) number
- K060578
- Product code
- JKR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-30
- Date received
- 2006-03-06
- Regulation
- 862.1140
- Classification name
- Radioimmunoassay, Calcitonin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL NORDSTROM
- Address
- 9336 Abraham Way Santee CA US 92071 92071
FDA Registration Numbers#
- 8032314
- 3002800697
- 2032839
- 2020726
- 1222302
- 2182595
- 9610126
- 2245285
- 2025099
- 3002806944
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JKR #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Decision Summary