Active Intact PTH
FDA 510(k) K973514 · Diagnostic Systems Laboratories, Inc.
510(k) numberK973514
Submission
- Device name
- Active Intact PTH
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- September 17, 1997
- Decision date
- October 31, 1997
- 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
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| 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 |
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| K981871 | C-Reactive Protein Elisa, Model Number DSL-10-42100DCK · Traditional | 11/09/1998SE |
| K973244 | Active Psa Irma (DSL-9700)LTJ · Traditional | 08/03/1998SE |
| K973243 | Active Psa Elisa (DSL-10-9700)LTJ · Traditional | 08/03/1998SE |
| K981607 | Active Renin Irma Model Number DSL-25100CIB · Traditional | 05/27/1998SE |
Questions and answers
When was Active Intact PTH cleared by the FDA?
Active Intact PTH (K973514) received a 510(k) decision of Substantially Equivalent on October 31, 1997, 44 days after the submission was received.
What is the product code of K973514?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.