Ventrex Coated Tube Intact PTH
FDA 510(k) K913434 · Ventrex Laboratories, Inc.
510(k) numberK913434
Submission
- Device name
- Ventrex Coated Tube Intact PTH
- Applicant
- Ventrex Laboratories, Inc.
Portland, ME, US - Received
- August 1, 1991
- Decision date
- October 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K914554 | Specific Ige Eia-Turbo AssayDHB · Traditional | 03/13/1992SE |
| K913833 | Ventrex Allergen DiscDHB · Traditional | 02/21/1992SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | 02/21/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 02/07/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | 01/17/1991SE |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | 12/07/1990SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | 07/31/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
| K895648 | Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
Questions and answers
When was Ventrex Coated Tube Intact PTH cleared by the FDA?
Ventrex Coated Tube Intact PTH (K913434) received a 510(k) decision of Substantially Equivalent on October 25, 1991, 85 days after the submission was received.
What is the product code of K913434?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.