The following data is part of a premarket notification filed by Endocrine-metabolic Center with the FDA for Emc-m-180, T3 Uptake - 100 Tubes.
| Device ID | K800188 |
| 510k Number | K800188 |
| Device Name: | EMC-M-180, T3 UPTAKE - 100 TUBES |
| Classification | Radioassay, Triiodothyronine Uptake |
| Applicant | ENDOCRINE-METABOLIC CENTER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-29 |
| Decision Date | 1980-02-13 |