The following data is part of a premarket notification filed by General Life Biotechnology Co., Ltd. with the FDA for Glb Benecheck Premium Glu Monitoring System.
| Device ID | K123090 |
| 510k Number | K123090 |
| Device Name: | GLB BENECHECK PREMIUM GLU MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | GENERAL LIFE BIOTECHNOLOGY CO., LTD. 27001 LA PAZ ROAD SUITE 266B Mission Viejo, CA 92691 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee GENERAL LIFE BIOTECHNOLOGY CO., LTD. 27001 LA PAZ ROAD SUITE 266B Mission Viejo, CA 92691 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-11-22 |
| Summary: | summary |