K854876 is an FDA 510(k) clearance for the ALDOSTERONE DIRECT RIA KIT. This device is classified as a Radioassay, Angiotensin Converting Enzyme (Class II - Special Controls, product code KQN).
Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on March 17, 1986, 101 days after receiving the submission on December 6, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1090.
| 510(k) Number | K854876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1985 |
| Decision Date | March 17, 1986 |
| Days to Decision | 101 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 |