510(k) K250085
- Device
- On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
- Applicant
- ACON Laboratories, Inc.
- 510(k) number
- K250085
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-10
- Date received
- 2025-01-13
- 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
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Catherine Shi
- Address
- 9440 Carroll Park Dr. San Diego CA US 92121 92121
FDA Registration Numbers
- 1450662
- 2030633
- 3012188053
- 3004009431
- 3030979885
- 1066444
- 3021286079
- 3013160357
- 3004145393
- 3022418645
- 3038419886
- 3005395953
- 3006371704
- 3007384659
- 3006733253
- 3015109923
- 3021611414
- 3022346573
- 1037998
- 3005862821
- 3016525500
- 9612841
- 3043013796
- 3011213605
- 3011979858
- 3013729860
- 3017520431
- 3030311186
- 3006755541
- 3008780388
- 3012725363
- 3031789039
- 1616487
- 3004183148
- 3015997711
- 9616530
- 3003422726
- 3043025312
- 3010131137
- 3005706626
- 3008700497
- 3008514395
- 3003902721
- 3008789114
- 3013223546
- 3007031103
- 3003917514
- 3004167884
- 3022147580
- 3013298431
- 3030186688
- 9610126
- 3002807314
- 3043513123
- 3018940143
- 3009456923
- 3015525148
- 3003674698
- 3008810357
- 3014302067
- 3009129531
- 3010713600
- 3012014399
- 3007421145
- 1649661
- 3005627859
- 3010564249
- 3004043187
- 3016863723
- 3014585508
- 3009171251
- 9616936
- 3005644014
- 2954323
- 3005360469
- 3012421607
- 3008382007
- 3007594734
- 2531491
- 2953359
Source Documents
510(k) summary PDF not indicated by FDA
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