K903188 is an FDA 510(k) clearance for the ABBOTT VISION LYTE (TM) SODIUM. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 10, 1990, 53 days after receiving the submission on July 19, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K903188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1990 |
| Decision Date | September 10, 1990 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |