The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Gl Goodlife Series Blood Glucose Monitoring Sysmtem.
| Device ID | K113307 |
| 510k Number | K113307 |
| Device Name: | GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | HMD BIOMEDICAL, INC. No 181 Minsheng St, Xinpu Township Hsinchu County, TW 305 |
| Contact | Jessica Tung |
| Correspondent | Jessica Tung HMD BIOMEDICAL, INC. No 181 Minsheng St, Xinpu Township Hsinchu County, TW 305 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2012-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00389154000709 | K113307 | 000 |
| 03891450006004 | K113307 | 000 |
| 00857596008008 | K113307 | 000 |
| 00857596008022 | K113307 | 000 |
| 00857596008046 | K113307 | 000 |
| 00868665000069 | K113307 | 000 |
| 00868665000076 | K113307 | 000 |
| 00389154000075 | K113307 | 000 |
| 00389154000204 | K113307 | 000 |
| 00389154000389 | K113307 | 000 |
| 00389154000549 | K113307 | 000 |
| 00389154000587 | K113307 | 000 |
| 00389145000600 | K113307 | 000 |
| 00389154000624 | K113307 | 000 |
| 00389154000631 | K113307 | 000 |
| 00389154000686 | K113307 | 000 |
| 04711200721034 | K113307 | 000 |