The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Angiotensin Converting Enzyme Assay Sys.
Device ID | K791712 |
510k Number | K791712 |
Device Name: | ANGIOTENSIN CONVERTING ENZYME ASSAY SYS |
Classification | Radioassay, Angiotensin Converting Enzyme |
Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQN |
CFR Regulation Number | 862.1090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-31 |
Decision Date | 1979-09-19 |