Elsa-Pth
FDA 510(k) K950211 · Cis-Us, Inc.
510(k) numberK950211
Submission
- Device name
- Elsa-Pth
- Applicant
- Cis-Us, Inc.
Bedford, MA, US - Received
- January 19, 1995
- Decision date
- April 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K951708 | Elsa-HctJKR · Traditional | 09/05/1995SE |
| K890799 | Curietron 192 High Dose RateJAQ · Traditional | 10/27/1989SE |
| K882449 | Cesium 137 Source, Model CSM-40IWI · Traditional | 04/14/1989SE |
| K871502 | Personnel Protective ShieldKPY · Traditional | 05/08/1987SE |
| K865027 | Irradiator for Biological Materials, IBL-137CMOT · Traditional | 02/26/1987SE |
| K863778 | Venticis IIIYT · Traditional | 10/27/1986SE |
| K860823 | Elsa-Prol Immunoradiometric Assay KitCFT · Traditional | 08/19/1986SE |
| K860824 | Tshk-Nn Ria KitJLW · Traditional | 04/28/1986SE |
Questions and answers
When was Elsa-Pth cleared by the FDA?
Elsa-Pth (K950211) received a 510(k) decision of Substantially Equivalent on April 13, 1995, 84 days after the submission was received.
What is the product code of K950211?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.