The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Fekal Con-trate System.
Device ID | K830769 |
510k Number | K830769 |
Device Name: | FEKAL CON-TRATE SYSTEM |
Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
Applicant | TREND SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLI |
CFR Regulation Number | 862.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-11 |
Decision Date | 1983-04-05 |