The following data is part of a premarket notification filed by Eumed Biotechnology Co., Ltd. with the FDA for Eukare.
| Device ID | K062892 |
| 510k Number | K062892 |
| Device Name: | EUKARE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | EUMED BIOTECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen EUMED BIOTECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
| Product Code | CGA |
| 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 | 2006-09-26 |
| Decision Date | 2007-01-22 |
| Summary: | summary |