Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001
FDA 510(k) K031534 · Scantibodies Laboratory, Inc.
510(k) numberK031534
Submission
- Device name
- Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001
- Applicant
- Scantibodies Laboratory, Inc.
Santee, CA, US - Received
- May 16, 2003
- Decision date
- July 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1545
- Specialty
- Clinical Chemistry
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| K232791 | Access Intact PTHCEW · Traditional | Beckman Coulter, Inc. | 03/01/2024SE |
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| K190702 | Lumipulse G whole PTHCEW · Traditional | Fujirebio Diagnostics,Inc. | 08/30/2019SE |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/23/2017SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | Immunodiagnostic Systems , Ltd. | 01/31/2017SE |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 06/22/2015SE |
| K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/05/2014SE |
| K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 11/08/2013SE |
| K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics | 03/21/2013SE |
More from Siemens Healthcare Diagnostics
| 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 |
| K021032 | Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100CKG · Traditional | 06/03/2002SE |
| K004038 | Total PTH Immunoradiometric Assay(Irma) Diagnostic Kit, Model 3KG600CEW · Traditional | 04/30/2001SE |
Questions and answers
When was Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001 cleared by the FDA?
Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001 (K031534) received a 510(k) decision of Substantially Equivalent on July 30, 2003, 75 days after the submission was received.
What is the product code of K031534?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.