K192785 is an FDA 510(k) clearance for the OptiScanner® 5000 Glucose Monitoring System. This device is classified as a Pump, Infusion, Analytical Sampling (Class II - Special Controls, product code LZF).
Submitted by Optiscan Biomedical Corporation (Hayward, US). The FDA issued a Cleared decision on February 5, 2020, 128 days after receiving the submission on September 30, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K192785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2019 |
| Decision Date | February 05, 2020 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LZF - Pump, Infusion, Analytical Sampling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |