510(k) K213131

Device: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Applicant: Roche Diabetes Care GmbH
510(k) number: K213131
Product code: NBW
Decision: Substantially Equivalent (SESE)
Decision date: 2023-08-10
Date received: 2021-09-27
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: Wolfgang Handel
Address: Sandhofer Strasse 116 Mannheim DE 68305 68305

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

510(k) summary PDF

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