510(k) K240640
- Device
- Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
- Applicant
- Sejoy Biomedical Co., Ltd.
- 510(k) number
- K240640
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-08
- Date received
- 2024-03-06
- Regulation
- 862.1345
- Classification name
- System, Test, Blood Glucose, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Yinting Lan
- Address
- Area C, Bldg. 2, #365 Wuzhou Rd. Yuhang Economic Development Zone Hangzhou City CN 311100 311100
FDA Registration Numbers
- 9611444
- 3007171717
- 3006537560
- 3004637226
- 1000113657
- 2029275
- 3003674698
- 3030311186
- 3008789114
- 1832216
- 3022346573
- 3033530347
- 3009901017
- 3007499349
- 3005644014
- 3004130086
- 3002807314
- 3011121740
- 3011061417
- 3016525500
- 3003600763
- 3010852191
- 3030186688
- 3014353121
- 3005862821
- 3033394445
- 9615507
- 3011979858
- 3015997711
- 1832816
- 3011065399
- 3030978471
- 2954323
- 3003422726
- 3004167884
- 3007031103
- 3009171251
- 1219029
- 3003741676
- 3013957847
- 3005393828
- 3016863723
- 3010564249
- 3007594734
- 3017550662
- 3015188281
- 3004043187
- 3008573045
- 1220477
- 3014353045
- 3007421145
- 3012014399
- 3007710663
- 3021286079
- 3004009431
- 3015109923
- 3004183148
- 3022147580
- 3005621222
- 3005627859
- 3017500903
- 1450743
- 2953359
- 3008514395
- 1220649
- 3003917514
- 3013160357
- 3042026207
- 3042364147
- 3014302067
- 3017520431
- 2030633
- 3003902721
- 1000134386
- 3011536730
- 3017086896
- 3009204541
- 3017548799
- 3026260647
- 3032948391
Source Documents
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