The following data is part of a premarket notification filed by Collaborative Research, Inc. with the FDA for Thyroxine Emia.
| Device ID | K840241 |
| 510k Number | K840241 |
| Device Name: | THYROXINE EMIA |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | COLLABORATIVE RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-20 |
| Decision Date | 1984-03-30 |