Submission Details
| 510(k) Number | K190564 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 2019 |
| Decision Date | June 02, 2019 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
Jun 2019
Decision
89d
Days
Class 2
Risk
About This 510(k) Submission
K190564 is an FDA 510(k) clearance for the Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB, 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 2, 2019, 89 days after receiving the submission on March 5, 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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