K833933 is an FDA 510(k) clearance for the ACE COLOR TEST. This device is classified as a Radioassay, Angiotensin Converting Enzyme (Class II - Special Controls, product code KQN).
Submitted by Hana Biologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 130 days after receiving the submission on November 14, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1090.
| 510(k) Number | K833933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1983 |
| Decision Date | March 23, 1984 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KQN — Radioassay, Angiotensin Converting Enzyme |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1090 |