The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Glucocard Shine Connex Blood Glucose Monitoring System, Glucocard Shine Express Blood Glucose Monitoring System.
| Device ID | K181273 |
| 510k Number | K181273 |
| Device Name: | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | i-SENS, Inc. 43, Banpo-daero 82-gil, Seocho-gu Seoul, KR 06646 |
| Contact | Joon Ho Jung |
| Correspondent | Joon Ho Jung i-SENS, Inc. 43, Banpo-daero 82-gil, Seocho-gu Seoul, KR 06646 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-14 |
| Decision Date | 2018-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885325001768 | K181273 | 000 |