The following data is part of a premarket notification filed by Amersham Corp. with the FDA for T-3 Uptake (maa) Kit.
Device ID | K790461 |
510k Number | K790461 |
Device Name: | T-3 UPTAKE (MAA) KIT |
Classification | Radioassay, Triiodothyronine Uptake |
Applicant | AMERSHAM 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 | 1979-03-05 |
Decision Date | 1979-05-03 |