The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Eme Self Monitoring Blood Glucose System, Eme Pro Self Monitoring Blood Glucose System.
| Device ID | K112901 |
| 510k Number | K112901 |
| Device Name: | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | EPS BIO TECHNOLOGY CORP. No.8, R&D Rd. III, Hsinchu Science Park, Hsinchu City, TW 30077 |
| Contact | Cynthia Hung |
| Correspondent | Cynthia Hung EPS BIO TECHNOLOGY CORP. No.8, R&D Rd. III, Hsinchu Science Park, Hsinchu City, TW 30077 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30856276008827 | K112901 | 000 |
| 00856276008819 | K112901 | 000 |
| B492301500 | K112901 | 000 |
| 00850031608702 | K112901 | 000 |