The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Gal-1a Blood Glucose Monitoring System.
| Device ID | K113208 |
| 510k Number | K113208 |
| Device Name: | GAL-1A 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 | 2011-11-01 |
| Decision Date | 2012-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10732671209426 | K113208 | 000 |
| 00732671009425 | K113208 | 000 |
| 00732671009418 | K113208 | 000 |
| 00732671009401 | K113208 | 000 |