STIKSEP-T3 Kit
FDA 510(k) K780486 · Nuclear Diagnostics, Inc.
510(k) numberK780486
Submission
- Device name
- STIKSEP-T3 Kit
- Applicant
- Nuclear Diagnostics, Inc.
Mchenry, IL, US - Received
- March 27, 1978
- Decision date
- April 28, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEE – Radioimmunoassay, Thyroxine-Binding Globulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1685
- Specialty
- Clinical Chemistry
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Questions and answers
When was STIKSEP-T3 Kit cleared by the FDA?
STIKSEP-T3 Kit (K780486) received a 510(k) decision of Substantially Equivalent on April 28, 1978, 32 days after the submission was received.
What is the product code of K780486?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.