Qlia T Uptake Assay
FDA 510(k) K883971 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK883971
Submission
- Device name
- Qlia T Uptake Assay
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- September 20, 1988
- Decision date
- October 25, 1988
- 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 Qlia T Uptake Assay cleared by the FDA?
Qlia T Uptake Assay (K883971) received a 510(k) decision of Substantially Equivalent on October 25, 1988, 35 days after the submission was received.
What is the product code of K883971?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.