K001761 is an FDA 510(k) clearance for the STATLYTE NA/K/CL/LI ANALYZER. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on August 7, 2000, 59 days after receiving the submission on June 9, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K001761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2000 |
| Decision Date | August 07, 2000 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |