K191038 is an FDA 510(k) clearance for the On Call Express Voice Blood Glucose Monitoring System. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on June 12, 2019, 55 days after receiving the submission on April 18, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K191038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2019 |
| Decision Date | June 12, 2019 |
| Days to Decision | 55 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |