Submission Details
| 510(k) Number | K240640 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 06, 2024 |
| Decision Date | October 08, 2024 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
Oct 2024
Decision
216d
Days
Class 2
Risk
About This 510(k) Submission
K240640 is an FDA 510(k) clearance for the Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Sejoy Biomedical Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on October 8, 2024, 216 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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