The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Ace Color Test.
| Device ID | K833933 |
| 510k Number | K833933 |
| Device Name: | ACE COLOR TEST |
| Classification | Radioassay, Angiotensin Converting Enzyme |
| Applicant | HANA BIOLOGICS, 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 | 1983-11-14 |
| Decision Date | 1984-03-23 |