The following data is part of a premarket notification filed by Hyperion, Inc. with the FDA for Computing Spectrophotometer Bio-chemistry Analyzer.
| Device ID | K855149 |
| 510k Number | K855149 |
| Device Name: | COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | HYPERION, INC. 14100 S.W. 136TH ST. Miami, FL 33186 |
| Contact | Harter |
| Correspondent | Harter 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 | 1985-12-26 |
| Decision Date | 1986-02-11 |