The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Q.steps Biometer G/c Dual Monitoring System.
| Device ID | K050182 |
| 510k Number | K050182 |
| Device Name: | Q.STEPS BIOMETER G/C DUAL 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 |
| Subsequent Product Code | CHH |
| 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 | 2005-01-27 |
| Decision Date | 2005-08-09 |
| Summary: | summary |