The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for T3 Uptake.
Device ID | K841927 |
510k Number | K841927 |
Device Name: | T3 UPTAKE |
Classification | Radioassay, Triiodothyronine Uptake |
Applicant | SYNCOR INTL. CORP. 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 | 1984-05-10 |
Decision Date | 1984-06-25 |