The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Thyroxine Monoclonal Antibody Solid Phase Radioimm.
| Device ID | K904816 |
| 510k Number | K904816 |
| Device Name: | THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | J Arnsberger |
| Correspondent | J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1991-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830022481 | K904816 | 000 |
| 00817830022474 | K904816 | 000 |
| 00817830022467 | K904816 | 000 |