K884771 is an FDA 510(k) clearance for the IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY. This device is classified as a Electrode, Ion Specific, Calcium (Class II - Special Controls, product code JFP).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 10, 1989, 88 days after receiving the submission on November 14, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K884771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1988 |
| Decision Date | February 10, 1989 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFP — Electrode, Ion Specific, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |