London Diagnostics Lumatag(Tm) Intact PTH Assay
FDA 510(k) K903130 · London Diagnostics, Inc.
510(k) numberK903130
Submission
- Device name
- London Diagnostics Lumatag(Tm) Intact PTH Assay
- Applicant
- London Diagnostics, Inc.
Eden Prairie, MN, US - Received
- July 17, 1990
- Decision date
- September 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K914835 | Lumatag Free T4 Chemiluminescence AssayCEC · Traditional | 12/17/1991SE |
| K911985 | Lumatag T4 Chemiluminescence AssayCDX · Traditional | 08/02/1991SE |
| K912858 | London Diagnostics Lumatag(R) HGH Chem Immun AssayCFL · Traditional | 07/30/1991SE |
| K905814 | Lumatag(R) FSH Chemiluminescence Immunometri AssayCGJ · Traditional | 02/04/1991SE |
| K904458 | Lumatag(Tm) Prolactin Diagnostic Kit/ModificationCFT · Traditional | 10/12/1990SE |
| K903195 | London Diagnostics Lumatag (R) Ige Chem. Imm AssayDGC · Traditional | 08/02/1990SE |
| K902443 | Lumatag(Tm) LH Diagnostic KitCEP · Traditional | 08/02/1990SE |
| K901484 | Lumatag(Tm) HCG Chemiluminescence ImmunometricJHI · Traditional | 05/01/1990SE |
| K901075 | Lumatag(Tm) Ferritin Chemiluminescence Immunomet.DBF · Traditional | 04/02/1990SE |
| K881443 | Lumatag(Tm) TSH Chemiluminescence Immuno. AssayJLW · Traditional | 05/27/1988SE |
Questions and answers
When was London Diagnostics Lumatag(Tm) Intact PTH Assay cleared by the FDA?
London Diagnostics Lumatag(Tm) Intact PTH Assay (K903130) received a 510(k) decision of Substantially Equivalent on September 25, 1990, 70 days after the submission was received.
What is the product code of K903130?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.