The following data is part of a premarket notification filed by Tokyo Boeki Medisys Inc. with the FDA for Biolis 12i.
| Device ID | K110520 |
| 510k Number | K110520 |
| Device Name: | BIOLIS 12I |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | TOKYO BOEKI MEDISYS INC. 5105 FAIROAKS ROAD Durham, NC 27712 |
| Contact | James M Clinton |
| Correspondent | James M Clinton TOKYO BOEKI MEDISYS INC. 5105 FAIROAKS ROAD Durham, NC 27712 |
| Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-23 |
| Decision Date | 2012-03-23 |
| Summary: | summary |