Ventrezyme T4U Immunoassay T4U
FDA 510(k) K841024 · Ventrex Laboratories, Inc.
510(k) numberK841024
Submission
- Device name
- Ventrezyme T4U Immunoassay T4U
- Applicant
- Ventrex Laboratories, Inc.
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- May 9, 1984
- 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 Ventrezyme T4U Immunoassay T4U cleared by the FDA?
Ventrezyme T4U Immunoassay T4U (K841024) received a 510(k) decision of Substantially Equivalent on May 9, 1984, 58 days after the submission was received.
What is the product code of K841024?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.