The following data is part of a premarket notification filed by Tokyo Boeki Medisys Inc. with the FDA for Prestige 24i; Biolis 24i; Mgc 240.
| Device ID | K103531 |
| 510k Number | K103531 |
| Device Name: | PRESTIGE 24I; BIOLIS 24I; MGC 240 |
| Classification | Hexokinase, Glucose |
| 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 | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-01 |
| Decision Date | 2011-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04580262049826 | K103531 | 000 |
| 04580262049819 | K103531 | 000 |
| 04580262049802 | K103531 | 000 |
| 04580262046825 | K103531 | 000 |
| 04580262046818 | K103531 | 000 |
| 04580262016002 | K103531 | 000 |
| 04580262010222 | K103531 | 000 |
| 04580262010208 | K103531 | 000 |