The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Gal-1f Blood Glucose Monitoring System, Gal-1f Pro Blood Glucose Monitoring System.
| Device ID | K142689 |
| 510k Number | K142689 |
| Device Name: | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Apex BioTechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, TW 30078 |
| Contact | Hsue-mei Lee |
| Correspondent | Hsue-mei Lee Apex BioTechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, TW 30078 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-08-06 |
| Summary: | summary |