The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Q.steps Biometer G Blood Glucose Monitoring System.
| Device ID | K033627 |
| 510k Number | K033627 |
| Device Name: | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BIOMEDIX, INC. 40471 ENCYCLOPEDIA CIRCLE Fremont, CA 94538 |
| Contact | Judy S Chen |
| Correspondent | Judy S Chen BIOMEDIX, INC. 40471 ENCYCLOPEDIA CIRCLE Fremont, CA 94538 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-19 |
| Decision Date | 2004-05-21 |
| Summary: | summary |