K844586 is an FDA 510(k) clearance for the IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS. This device is classified as a Analyzer, Chemistry, Micro, For Clinical Use (Class I - General Controls, product code JJF).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on December 11, 1984, 18 days after receiving the submission on November 23, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K844586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1984 |
| Decision Date | December 11, 1984 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJF — Analyzer, Chemistry, Micro, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2170 |