Submission Details
| 510(k) Number | K231192 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 2023 |
| Decision Date | January 19, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
RIGHTEST Blood Glucose Monitoring System Max Tel
Jan 2024
Decision
267d
Days
Class 2
Risk
About This 510(k) Submission
K231192 is an FDA 510(k) clearance for the RIGHTEST Blood Glucose Monitoring System Max Tel, 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 January 19, 2024, 267 days after receiving the submission on April 27, 2023. 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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