Radioimmunoassay, Total Triiodothronie
FDA 510(k) K810351 · Endocrine-Metabolic Center
510(k) numberK810351
Submission
- Device name
- Radioimmunoassay, Total Triiodothronie
- Applicant
- Endocrine-Metabolic Center
Mchenry, IL, US - Received
- February 10, 1981
- Decision date
- February 23, 1981
- 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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| K983439 | Abbott Architect Free T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
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| K974027 | Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator PackCDP · Traditional | Alfa Biotech (Uk) , Ltd. | 02/02/1998SE |
| K974634 | Immulite Free T3CDP · Traditional | Diagnostic Products Corp. | 01/02/1998SE |
| K973966 | Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
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|---|---|---|
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| K811993 | Radioimmunoassay, Follicle StimulatingCGJ · Traditional | 08/03/1981SE |
| K811994 | Radioimmunoassay Luteinizing HormoneCEP · Traditional | 07/27/1981SE |
| K810948 | Radioimmunoassay Thyroid Stim. Horm. KitJLW · Traditional | 04/17/1981SE |
| K800188 | EMC-M-180, T3 Uptake - 100 TubesKHQ · Traditional | 02/13/1980SE |
| K800187 | EMC-M-175, Thyroxine - 100 TubesCDX · Traditional | 02/13/1980SE |
| K790602 | Ria, DIGNXIN-125-IDPB · Traditional | 07/30/1979SE |
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Questions and answers
When was Radioimmunoassay, Total Triiodothronie cleared by the FDA?
Radioimmunoassay, Total Triiodothronie (K810351) received a 510(k) decision of Substantially Equivalent on February 23, 1981, 13 days after the submission was received.
What is the product code of K810351?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.