Free T4 Radioimmunoassay Kit
FDA 510(k) K821241 · Bioclinical Group
510(k) numberK821241
Submission
- Device name
- Free T4 Radioimmunoassay Kit
- Applicant
- Bioclinical Group
Mchenry, IL, US - Received
- April 29, 1982
- Decision date
- June 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Roche Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K862968 | Free T3 Radioimmunoassay KitKHQ · Traditional | 09/25/1986SE |
| K853837 | Lh/Fsh Radioimmunoassay KitCEP · Traditional | 10/16/1985SE |
| K832638 | Cortisol Radioimmunoassay KitCGR · Traditional | 09/12/1983SE |
| K823005 | Bio Mag Free T4 Radioimmunoassay KitCEC · Traditional | 12/15/1982SE |
| K823004 | Bio Mag Total T4 Radioimmunoassay KitCDX · Traditional | 11/05/1982SE |
| K822840 | Radioimmunoassay, Human ChorrionicJHI · Traditional | 10/27/1982SE |
| K822515 | B-Hcg Radioimmunoassay KitJHI · Traditional | 09/14/1982SE |
| K821101 | Total Radioimmunoassay KitCDX · Traditional | 05/05/1982SE |
Questions and answers
When was Free T4 Radioimmunoassay Kit cleared by the FDA?
Free T4 Radioimmunoassay Kit (K821241) received a 510(k) decision of Substantially Equivalent on June 1, 1982, 33 days after the submission was received.
What is the product code of K821241?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.