The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning's Magic T3(125i) Radioimmuno-.
Device ID | K832353 |
510k Number | K832353 |
Device Name: | CORNING'S MAGIC T3(125I) RADIOIMMUNO- |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-18 |
Decision Date | 1983-08-31 |