The following data is part of a premarket notification filed by Endocrine-metabolic Center with the FDA for Emc-m-175, Thyroxine - 100 Tubes.
| Device ID | K800187 |
| 510k Number | K800187 |
| Device Name: | EMC-M-175, THYROXINE - 100 TUBES |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | ENDOCRINE-METABOLIC CENTER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-29 |
| Decision Date | 1980-02-13 |