Submission Details
| 510(k) Number | K240637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 06, 2024 |
| Decision Date | November 04, 2024 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
RIGHTEST Blood Glucose Monitoring System Max Tel
Nov 2024
Decision
243d
Days
Class 2
Risk
About This 510(k) Submission
K240637 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 November 4, 2024, 243 days after receiving the submission on March 6, 2024. 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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