Access Free T4 Reagents on the Access Immunoassay Analyzer
FDA 510(k) K982250 · Beckman Instruments, Inc.
510(k) numberK982250
Submission
- Device name
- Access Free T4 Reagents on the Access Immunoassay Analyzer
- Applicant
- Beckman Instruments, Inc.
Chaska, MN, US - Received
- June 26, 1998
- Decision date
- July 14, 1998
- 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
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
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|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
| K973928 | Beckman Urine Protein Calibrator (Ucal)JIX · Traditional | 12/01/1997SE |
Questions and answers
When was Access Free T4 Reagents on the Access Immunoassay Analyzer cleared by the FDA?
Access Free T4 Reagents on the Access Immunoassay Analyzer (K982250) received a 510(k) decision of Substantially Equivalent on July 14, 1998, 18 days after the submission was received.
What is the product code of K982250?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.