Corning Magic Single Step Free T4
FDA 510(k) K832381 · Corning Medical & Scientific
510(k) numberK832381
Submission
- Device name
- Corning Magic Single Step Free T4
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- July 19, 1983
- Decision date
- September 1, 1983
- 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 Corning Magic Single Step Free T4 cleared by the FDA?
Corning Magic Single Step Free T4 (K832381) received a 510(k) decision of Substantially Equivalent on September 1, 1983, 44 days after the submission was received.
What is the product code of K832381?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.