Elegance FT4 Elisa
FDA 510(k) K922284 · Bioclone Australia Pty , Ltd.
510(k) numberK922284
Submission
- Device name
- Elegance FT4 Elisa
- Applicant
- Bioclone Australia Pty , Ltd.
Washington, DC, US - Received
- May 15, 1992
- Decision date
- July 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code CEC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240273 | Access Free T4CEC · Traditional | Beckman Coulter, Inc. | 03/06/2024SE |
| K220456 | Elecsys FT4 IVCEC · Traditional | Roche Diagnostics | 04/07/2023SE |
| K182423 | Maglumi 2000 FT4CEC · Traditional | Shenzhen New Industries Biomedical Engineering… | 10/04/2018SE |
| 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 |
More from Roche Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K935049 | Elegance Neonatal TSH ElisaJLW · Traditional | 10/03/1994SE |
| K910419 | Bioclone's Elegance Ige Elisa KitDGC · Traditional | 06/21/1991SE |
| K910420 | Bioclone's Elegance HCG Elisa KitJHI · Traditional | 02/26/1991SE |
| K905099 | Elegance TSH ElisaJLW · Traditional | 12/18/1990SE |
| K905098 | Elegance GH ElisaCFL · Traditional | 12/06/1990SE |
| K904822 | Elegance Ferritin ElisaDBF · Traditional | 11/29/1990SE |
| K904387 | Bioclones Elegance LH Elisa KitCEP · Traditional | 11/06/1990SE |
| K904483 | Elegance Prolactin ElisaCFT · Traditional | 11/05/1990SE |
| K904405 | Bioclones Elegance FSH Elisa KitCGJ · Traditional | 10/26/1990SE |
Questions and answers
When was Elegance FT4 Elisa cleared by the FDA?
Elegance FT4 Elisa (K922284) received a 510(k) decision of Substantially Equivalent on July 10, 1992, 56 days after the submission was received.
What is the product code of K922284?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.