The following data is part of a premarket notification filed by Broadmaster Biotech Corporation with the FDA for Glucose Shepherd Blood Glucose Monitoring System.
| Device ID | K102316 |
| 510k Number | K102316 |
| Device Name: | GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BROADMASTER BIOTECH CORPORATION 7F, NO. 168-2, LIANCHENG Zhonghe City, TW 23553 |
| Contact | Roger Lai |
| Correspondent | Roger Lai BROADMASTER BIOTECH CORPORATION 7F, NO. 168-2, LIANCHENG Zhonghe City, TW 23553 |
| Product Code | CGA |
| 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 | 2010-08-16 |
| Decision Date | 2011-10-07 |
| Summary: | summary |