K823480 is an FDA 510(k) clearance for the IL 943 FLAME PHOTOMETER. This device is classified as a Flame Emission Photometer For Clinical Use (Class I - General Controls, product code JJO).
Submitted by Instrumentation Laboratory CO (Walker, US). The FDA issued a Cleared decision on January 9, 1983, 47 days after receiving the submission on November 23, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2540.
| 510(k) Number | K823480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1982 |
| Decision Date | January 09, 1983 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJO — Flame Emission Photometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2540 |