The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ace Activity Microvial Test Set.
| Device ID | K821011 |
| 510k Number | K821011 |
| Device Name: | ACE ACTIVITY MICROVIAL TEST SET |
| 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 | 1982-04-12 |
| Decision Date | 1982-05-03 |