The following data is part of a premarket notification filed by Hyperion, Inc. with the FDA for Hy-prep System.
| Device ID | K913809 |
| 510k Number | K913809 |
| Device Name: | HY-PREP SYSTEM |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | HYPERION, INC. 14100 S.W. 136TH ST. Miami, FL 33186 |
| Contact | Gregory Stamatis |
| Correspondent | Gregory Stamatis HYPERION, INC. 14100 S.W. 136TH ST. Miami, FL 33186 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1992-01-15 |