The following data is part of a premarket notification filed by Broadmaster Biotech Corperation with the FDA for Advocate Redi-code+bmb-ea001s Blood Glucose Monitoring System.
| Device ID | K120183 |
| 510k Number | K120183 |
| Device Name: | ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BROADMASTER BIOTECH CORPERATION 7F, NO. 168-2, LIANCHENG RD. Zhonghe Dist, TW 23553 |
| Contact | Roger Lai |
| Correspondent | Roger Lai BROADMASTER BIOTECH CORPERATION 7F, NO. 168-2, LIANCHENG RD. Zhonghe Dist, TW 23553 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-05-11 |
| Summary: | summary |