Calcitonin Ria Kit
FDA 510(k) K854240 · Diagnostic Systems Laboratories, Inc.
510(k) numberK854240
Submission
- Device name
- Calcitonin Ria Kit
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- October 21, 1985
- Decision date
- November 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K961043 | Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology)JKR · Traditional | Scantibodies Laboratory, Inc. | 05/06/1996SE |
| K945961 | Calcitonin Immunoassay KitJKR · Traditional | Nichols Institute Diagnostics | 11/20/1995SE |
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Questions and answers
When was Calcitonin Ria Kit cleared by the FDA?
Calcitonin Ria Kit (K854240) received a 510(k) decision of Substantially Equivalent on November 22, 1985, 32 days after the submission was received.
What is the product code of K854240?
The FDA product code is JKR – Radioimmunoassay, Calcitonin, a Class II (moderate risk) device regulated under 21 CFR 862.1140.