Submission Details
| 510(k) Number | K173139 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2017 |
| Decision Date | June 19, 2018 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
Jun 2018
Decision
263d
Days
Class 2
Risk
About This 510(k) Submission
K173139 is an FDA 510(k) clearance for the Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Bionime Corporation (Taichung City, TW). The FDA issued a Cleared decision on June 19, 2018, 263 days after receiving the submission on September 29, 2017. 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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