Ria Test Kit Sys. Damon Kiquisol Free
FDA 510(k) K781012 · Damon Corp.
510(k) numberK781012
Submission
- Device name
- Ria Test Kit Sys. Damon Kiquisol Free
- Applicant
- Damon Corp.
Mchenry, IL, US - Received
- June 16, 1978
- Decision date
- July 27, 1978
- 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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Questions and answers
When was Ria Test Kit Sys. Damon Kiquisol Free cleared by the FDA?
Ria Test Kit Sys. Damon Kiquisol Free (K781012) received a 510(k) decision of Substantially Equivalent on July 27, 1978, 41 days after the submission was received.
What is the product code of K781012?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.