The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventre/sep.
Device ID | K811423 |
510k Number | K811423 |
Device Name: | VENTRE/SEP |
Classification | Radioimmunoassay, Immunoreactive Insulin |
Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFP |
CFR Regulation Number | 862.1405 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-21 |
Decision Date | 1981-06-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VENTRE/SEP 73261348 1239862 Dead/Cancelled |
Ventrex Laboratories, Inc. 1980-05-08 |