The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Pointe 360.
| Device ID | K062118 |
| 510k Number | K062118 |
| Device Name: | POINTE 360 |
| Classification | Hexokinase, Glucose |
| Applicant | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-25 |
| Decision Date | 2007-07-13 |
| Summary: | summary |