Becton Dickinson Simultrac Component System
FDA 510(k) K925842 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK925842
Submission
- Device name
- Becton Dickinson Simultrac Component System
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Sparks, MD, US - Received
- November 18, 1992
- Decision date
- April 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Becton Dickinson Simultrac Component System cleared by the FDA?
Becton Dickinson Simultrac Component System (K925842) received a 510(k) decision of Substantially Equivalent on April 20, 1993, 153 days after the submission was received.
What is the product code of K925842?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.