Free T4 Ria Test Set
FDA 510(k) K813465 · Ventrex Laboratories, Inc.
510(k) numberK813465
Submission
- Device name
- Free T4 Ria Test Set
- Applicant
- Ventrex Laboratories, Inc.
Mchenry, IL, US - Received
- December 11, 1981
- Decision date
- December 31, 1981
- 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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| K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional | Roche Diagnostics | 01/27/2014SE |
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Questions and answers
When was Free T4 Ria Test Set cleared by the FDA?
Free T4 Ria Test Set (K813465) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 20 days after the submission was received.
What is the product code of K813465?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.