Elecsys FT4 Assay
FDA 510(k) K961489 · Boehringer Mannheim Corp.
510(k) numberK961489
Submission
- Device name
- Elecsys FT4 Assay
- Applicant
- Boehringer Mannheim Corp.
Concord, CA, US - Received
- April 18, 1996
- Decision date
- June 11, 1996
- 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 |
| 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 |
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|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Elecsys FT4 Assay cleared by the FDA?
Elecsys FT4 Assay (K961489) received a 510(k) decision of Substantially Equivalent on June 11, 1996, 54 days after the submission was received.
What is the product code of K961489?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.