Maglumi 2000 FT4
FDA 510(k) K182423 · Shenzhen New Industries Biomedical Engineering Co., Ltd.
510(k) numberK182423
Submission
- Device name
- Maglumi 2000 FT4
- Applicant
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
Shenzhen, CN - Received
- September 6, 2018
- Decision date
- October 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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| K220456 | Elecsys FT4 IVCEC · Traditional | Roche Diagnostics | 04/07/2023SE |
| K181233 | Elecsys FT4 IIICEC · Traditional | Roche Diagnostics | 09/18/2018SE |
| K173122 | Abbott Architect Free T4CEC · Special | Abbott Laboratories | 10/27/2017SE |
| K152422 | FREND Free T4 Test SystemCEC · Traditional | Nanoentek USA, Inc. | 02/17/2016SE |
| K132058 | Vidas FT4CEC · Traditional | Biomerieux S.A. | 06/08/2015SE |
| K140859 | Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional | Roche Diagnostics | 01/27/2014SE |
| K132249 | Advia Centaur FT4, Advia Centaur T4CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/13/2013SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerMRG · Traditional | 04/12/2024SE |
| K192547 | MAGLUMI 2000 HCG/ß-HCGDHA · Traditional | 01/17/2020SE |
| K191499 | MAGLUMI 2000 25-OH Vitamin DMRG · Traditional | 08/01/2019SE |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW · Traditional | 07/14/2017SE |
Questions and answers
When was Maglumi 2000 FT4 cleared by the FDA?
Maglumi 2000 FT4 (K182423) received a 510(k) decision of Substantially Equivalent on October 4, 2018, 28 days after the submission was received.
What is the product code of K182423?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.