The following data is part of a premarket notification filed by Ok Biotech Co., Ltd. with the FDA for Prodigy Iconnect Blood Glucose Monitoring System.
| Device ID | K142785 |
| 510k Number | K142785 |
| Device Name: | PRODIGY IConnect Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | OK BIOTECH CO., LTD. No. 91, Sec. 2, Gongdao 5th Road Hsinchu City, TW 30070 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min OK BIOTECH CO., LTD. No. 91, Sec. 2, Gongdao 5th Road Hsinchu City, TW 30070 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2015-12-17 |
| Summary: | summary |