CEW — Radioimmunoassay, Parathyroid Hormone Class II
FDA product code CEW covers "Radioimmunoassay, Parathyroid Hormone", a Class II medical device regulated under 21 CFR 862.1545. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |