The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Thyroid Binding Globulin.
Device ID | K772183 |
510k Number | K772183 |
Device Name: | THYROID BINDING GLOBULIN |
Classification | Radioimmunoassay, Thyroxine-binding Globulin |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEE |
CFR Regulation Number | 862.1685 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-25 |
Decision Date | 1977-12-20 |