The following data is part of a premarket notification filed by Hyperion, Inc. with the FDA for Microreader 4.
| Device ID | K935983 |
| 510k Number | K935983 |
| Device Name: | MICROREADER 4 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | HYPERION, INC. 14100 S.W. 136TH ST. Miami, FL 33186 |
| Contact | G. Gregory Stamatis |
| Correspondent | G. Gregory Stamatis HYPERION, INC. 14100 S.W. 136TH ST. Miami, FL 33186 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-14 |
| Decision Date | 1994-12-09 |