The following data is part of a premarket notification filed by Hmd Biomedical Inc. with the FDA for Glucoleader Enhance Blood Glucose Monitoring System.
| Device ID | K182428 |
| 510k Number | K182428 |
| Device Name: | GlucoLeader Enhance Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HMD BioMedical Inc. No. 181 Minsheng St., Xinpu Township Hsin Chu County, TW 30542 |
| Contact | Jen Ke-min |
| Correspondent | Ke-min Jen Chinese-European Industrial Research Society No. 58 Fu-Chiun St. Hsin-chu City, TW 30067 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-06 |
| Decision Date | 2019-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711200722291 | K182428 | 000 |
| 04711200723922 | K182428 | 000 |
| 04711200724202 | K182428 | 000 |
| 04711200724226 | K182428 | 000 |
| 04711200724240 | K182428 | 000 |
| 00850048540514 | K182428 | 000 |
| 00850048540521 | K182428 | 000 |
| 00810038634746 | K182428 | 000 |
| 10810038634866 | K182428 | 000 |
| 00850009854032 | K182428 | 000 |
| 00850009854049 | K182428 | 000 |
| 04711200722246 | K182428 | 000 |
| 04711200723892 | K182428 | 000 |