The following data is part of a premarket notification filed by Micobiomed Co, Ltd with the FDA for Veri-q Mgd-1001 Blood Glucose Monitoring System, Veri-q Plus Mgd-1001 Blood Glucose Monitoring System.
| Device ID | K123007 |
| 510k Number | K123007 |
| Device Name: | VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | MICOBIOMED CO, LTD 55-13, SINGEONJI-DONG Anseong, KR 456-781 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung MICOBIOMED CO, LTD 55-13, SINGEONJI-DONG Anseong, KR 456-781 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2013-06-19 |
| Summary: | summary |