CEW — Radioimmunoassay, Parathyroid Hormone Class II
FDA Device Classification
Classification Details
- Product Code
- CEW
- Device Class
- Class II
- Regulation Number
- 862.1545
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231927 | roche diagnostics | Elecsys PTH , Elecsys PTH STAT | March 22, 2024 |
| K232791 | beckman coulter | Access Intact PTH | March 1, 2024 |
| K221197 | ortho clinical diagnostics | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | September 5, 2023 |
| K190702 | fujirebio diagnostics | Lumipulse G whole PTH | August 30, 2019 |
| K163658 | siemens healthcare diagnostics | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | May 23, 2017 |
| K161158 | immunodiagnostic systems | IDS-iSYS Intact PTHN | January 31, 2017 |
| K150879 | diasorin | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration | June 22, 2015 |
| K133601 | siemens healthcare diagnostics | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY | February 5, 2014 |
| K132515 | diasorin | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS | November 8, 2013 |
| K121981 | siemens healthcare diagnostics | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY | March 21, 2013 |
| K103325 | immunodiagnostic systems | IDS-ISYS INTACT PTH | February 3, 2012 |
| K101921 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOST | October 22, 2010 |
| K070709 | roche diagnostics | ROCHE ELECSYS PTH TEST SYSTEM | July 13, 2007 |
| K063605 | tosoh bioscience | ST AIA-PACK INTACT PTH ASSAY | June 21, 2007 |
| K063232 | biokit | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH | June 19, 2007 |
| K070391 | roche diagnostics | ELECSYS PTH TEST SYSTEM | March 20, 2007 |
| K061190 | beckman coulter | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 | September 15, 2006 |
| K060420 | scantibodies laboratory | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY | March 1, 2006 |
| K060348 | scantibodies laboratory | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | February 27, 2006 |
| K053533 | diagnostic products corporation | IMMULITE/IMMULITE 1000 TURBO INTACT PTH | February 3, 2006 |