The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventre/sep Ferritin Ria.
Device ID | K790447 |
510k Number | K790447 |
Device Name: | VENTRE/SEP FERRITIN RIA |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-05 |
Decision Date | 1979-04-23 |