Triiodothyronine Ria System
FDA 510(k) K792539 · Radioimmunoassay, Inc.
510(k) numberK792539
Submission
- Device name
- Triiodothyronine Ria System
- Applicant
- Radioimmunoassay, Inc.
Mchenry, IL, US - Received
- December 10, 1979
- Decision date
- January 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDP – Radioimmunoassay, Total Triiodothyronine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1710
- Specialty
- Clinical Chemistry
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| K800106 | Luteinizing Hormone Radioimmunoassay SysCEP · Traditional | 02/13/1980SE |
| K792154 | Thyroid Stimulating HormoneJLW · Traditional | 11/13/1979SE |
| K792153 | Digoxin Radioimmunoassay SystemDPB · Traditional | 11/13/1979SE |
| K792036 | Cortisol Radioimmunoassay SystemCGR · Traditional | 10/30/1979SE |
| K780672 | 125 I-T4 Ria ReagentCDX · Traditional | 06/06/1978SE |
| K780671 | 125 I-T3 Uptake ReagentCEE · Traditional | 06/06/1978SE |
Questions and answers
When was Triiodothyronine Ria System cleared by the FDA?
Triiodothyronine Ria System (K792539) received a 510(k) decision of Substantially Equivalent on January 16, 1980, 37 days after the submission was received.
What is the product code of K792539?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.