The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Thyroxine (t4) Quantitative.
Device ID | K962211 |
510k Number | K962211 |
Device Name: | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE |
Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
Applicant | UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
Contact | Wuan T Lu |
Correspondent | Wuan T Lu UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
Product Code | KLI |
CFR Regulation Number | 862.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-10 |
Decision Date | 1996-07-08 |