The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Simultrac Component System.
| Device ID | K925842 |
| 510k Number | K925842 |
| Device Name: | BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 10 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 10 LOVETON CIRCLE Sparks, MD 21152 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-18 |
| Decision Date | 1993-04-20 |