The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Autosure Voice Ii Plus, Autosure Plus Blood Glucose Test Strips,contrex Plus Iii.
| Device ID | K113098 |
| 510k Number | K113098 |
| Device Name: | AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2012-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884389831216 | K113098 | 000 |