Submission Details
| 510(k) Number | K191038 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
On Call Express Voice Blood Glucose Monitoring System
Jun 2019
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K191038 is an FDA 510(k) clearance for the On Call Express Voice Blood Glucose Monitoring System, 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 review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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