Vitros Immunodiagnostics Products Intact PTH Reagent Pack, Vitros Immunodiagnostics Products Intact PTH Calibrators, Vit
FDA 510(k) K101921 · Ortho-Clinical Diagnostics
510(k) numberK101921
Submission
- Device name
- Vitros Immunodiagnostics Products Intact PTH Reagent Pack, Vitros Immunodiagnostics Products Intact PTH Calibrators, Vit
- Applicant
- Ortho-Clinical Diagnostics
Rochester, NY, US - Received
- July 9, 2010
- Decision date
- October 22, 2010
- 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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Questions and answers
When was Vitros Immunodiagnostics Products Intact PTH Reagent Pack, Vitros Immunodiagnostics Products Intact PTH Calibrators, Vit cleared by the FDA?
Vitros Immunodiagnostics Products Intact PTH Reagent Pack, Vitros Immunodiagnostics Products Intact PTH Calibrators, Vit (K101921) received a 510(k) decision of Substantially Equivalent on October 22, 2010, 105 days after the submission was received.
What is the product code of K101921?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.