Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit, Model 3KG002
FDA 510(k) K060420 · Scantibodies Laboratory, Inc.
510(k) numberK060420
Submission
- Device name
- Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit, Model 3KG002
- Applicant
- Scantibodies Laboratory, Inc.
Santee, CA, US - Received
- February 17, 2006
- Decision date
- March 1, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code CEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STATCEW · Traditional | Roche Diagnostics | 03/22/2024SE |
| K232791 | Access Intact PTHCEW · Traditional | Beckman Coulter, Inc. | 03/01/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | Ortho Clinical Diagnostics | 09/05/2023SE |
| 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 |
| 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 |
| K004038 | Total PTH Immunoradiometric Assay(Irma) Diagnostic Kit, Model 3KG600CEW · Traditional | 04/30/2001SE |
Questions and answers
When was Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit, Model 3KG002 cleared by the FDA?
Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit, Model 3KG002 (K060420) received a 510(k) decision of Substantially Equivalent on March 1, 2006, 12 days after the submission was received.
What is the product code of K060420?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.