Tipsep-Tbg Assay
FDA 510(k) K861735 · Nuclear Diagnostics, Inc.
510(k) numberK861735
Submission
- Device name
- Tipsep-Tbg Assay
- Applicant
- Nuclear Diagnostics, Inc.
Troy, MI, US - Received
- May 6, 1986
- Decision date
- June 13, 1986
- 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 Tipsep-Tbg Assay cleared by the FDA?
Tipsep-Tbg Assay (K861735) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 38 days after the submission was received.
What is the product code of K861735?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.