The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra System Thyroxine T4 Method.
| Device ID | K894575 |
| 510k Number | K894575 |
| Device Name: | TECHNICON RA SYSTEM THYROXINE T4 METHOD |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard Dwarica |
| Correspondent | Leonard Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-21 |
| Decision Date | 1989-10-04 |