The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Meg-2b Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control.
| Device ID | K120448 |
| 510k Number | K120448 |
| Device Name: | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL |
| Classification | Glucose Oxidase, Glucose |
| Applicant | APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Lisa Liu |
| Correspondent | Lisa Liu APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-14 |
| Decision Date | 2012-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40884389831206 | K120448 | 000 |
| 30888277365944 | K120448 | 000 |