Phadebas T3 U Test
510(k) K771078
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771078 | Date27 Jun 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KHQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1715
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Phadebas T3 U Test is a radioassay for triiodothyronine uptake, a diagnostic in vitro device used to measure thyroid function by assessing the binding capacity of thyroid-binding proteins in serum. It falls under the category of clinical chemistry assays and is designed to evaluate thyroid hormone metabolism indirectly through the uptake of radiolabeled triiodothyronine (T3).
This test is supplied as a single-use diagnostic kit for in vitro laboratory use, requiring no sterilization beyond manufacturer-provided packaging. It is classified under FDA product code KHQ and regulated under 21 CFR 862.1715, with a Traditional 510(k) clearance (K771078) granted in 1977. The device is intended for use in clinical chemistry laboratories and adheres to Class II special controls for radioassay applications. No MRI safety or reusable components are specified.
Other devices from Pharmacia, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Phadebas T3 U Test used for?
The Phadebas T3 U Test is a radioassay diagnostic device used to measure thyroid function by assessing the binding capacity of thyroid-binding proteins in serum, helping evaluate thyroid hormone metabolism indirectly through triiodothyronine uptake.
How is the Phadebas T3 U Test supplied and is it reusable?
The test is supplied as a single-use diagnostic kit for in vitro laboratory use, requiring no sterilization beyond manufacturer-provided packaging. It is not designed for reuse and should be discarded after single use.
What regulatory status does the Phadebas T3 U Test have?
The device has FDA 510(k) clearance with K number K771078 granted in 1977, classified under product code KHQ and regulated under 21 CFR 862.1715 as a Class II device with special controls for radioassay applications.
What are the specifications and intended use of the Phadebas T3 U Test?
The test is a clinical chemistry assay designed for in vitro laboratory use to evaluate thyroid hormone metabolism indirectly through the uptake of radiolabeled triiodothyronine (T3). It is intended for use in clinical chemistry laboratories to assess thyroid function.