The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura Control Solution.
| Device ID | K103278 |
| 510k Number | K103278 |
| Device Name: | ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION |
| Classification | Glucose Oxidase, Glucose |
| Applicant | i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul, KR 139-845 |
| Contact | Hyun Joon Oh |
| Correspondent | Hyun Joon Oh i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul, KR 139-845 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-05 |
| Decision Date | 2011-10-28 |
| Summary: | summary |