Immulite Free T4 (2-STEP)
FDA 510(k) K971792 · Diagnostic Products Corp.
510(k) numberK971792
Submission
- Device name
- Immulite Free T4 (2-STEP)
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- May 15, 1997
- Decision date
- July 25, 1997
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite Free T4 (2-STEP) cleared by the FDA?
Immulite Free T4 (2-STEP) (K971792) received a 510(k) decision of Substantially Equivalent on July 25, 1997, 71 days after the submission was received.
What is the product code of K971792?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.