The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Hl 568 Self Monitoring Blood Glucose System, Hl 568ba Self-moniroting Blood Glucose System.
| Device ID | K110074 |
| 510k Number | K110074 |
| Device Name: | HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, TW 235 |
| Contact | Sarah Su |
| Correspondent | Sarah Su HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, TW 235 |
| 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 | 2011-01-10 |
| Decision Date | 2012-05-25 |
| Summary: | summary |