Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology)
FDA 510(k) K961043 · Scantibodies Laboratory, Inc.
510(k) numberK961043
Submission
- Device name
- Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology)
- Applicant
- Scantibodies Laboratory, Inc.
Santee, CA, US - Received
- March 14, 1996
- Decision date
- May 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JKR – Radioimmunoassay, Calcitonin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1140
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252431 | Elecsys CalcitoninJKR · Traditional | Roche Diagnostics GmbH | 04/24/2026SE |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | Axis-Shield Diagnostics Limited | 12/21/2018SE |
| K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3JKR · Traditional | Roche Diagnostics | 12/04/2013SE |
| K060578 | Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)JKR · Traditional | Scantibodies Laboratory, Inc. | 08/30/2006SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | Diagnostic Products Corp. | 12/09/2002SE |
| K990073 | CalcitoninJKR · Traditional | Kmi Diagnostics, Inc. | 05/11/1999SE |
| K982491 | Sangui Biotech, Inc. Calcitonin Elisa KitJKR · Traditional | Sangui Biotech, Inc. | 09/03/1998SE |
| K964635 | Nichols Advantage Chemiluminescence Calcitonin KitJKR · Traditional | Nichols Institute Diagnostics | 05/21/1997SE |
| K945961 | Calcitonin Immunoassay KitJKR · Traditional | Nichols Institute Diagnostics | 11/20/1995SE |
| K951708 | Elsa-HctJKR · Traditional | Cis-Us, Inc. | 09/05/1995SE |
More from Cis-Us, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060578 | Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)JKR · Traditional | 08/30/2006SE |
| K060420 | Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit…CEW · Special | 03/01/2006SE |
| K060348 | Modification to: Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Special | 02/27/2006SE |
| K051888 | Total Intact PTH Immunoradiometric Assay (Coated Tube Version), Model 3KG013CEW · Traditional | 10/18/2005SE |
| K051810 | Whole PTH (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3KG014CEW · Traditional | 09/09/2005SE |
| K051150 | Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Traditional | 07/26/2005SE |
| K051141 | Whole PTH (1-84) Specific Immunochemiluminometric Assay (Icma), Model 3KG002CEW · Traditional | 07/26/2005SE |
| K050748 | Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011CKG · Traditional | 05/20/2005SE |
| K031534 | Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001CEW · Traditional | 07/30/2003SE |
| K021032 | Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100CKG · Traditional | 06/03/2002SE |
Questions and answers
When was Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology) cleared by the FDA?
Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology) (K961043) received a 510(k) decision of Substantially Equivalent on May 6, 1996, 53 days after the submission was received.
What is the product code of K961043?
The FDA product code is JKR – Radioimmunoassay, Calcitonin, a Class II (moderate risk) device regulated under 21 CFR 862.1140.