The following data is part of a premarket notification filed by Igen, Inc. with the FDA for Origen Analyzer.
| Device ID | K962166 |
| 510k Number | K962166 |
| Device Name: | ORIGEN ANALYZER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | IGEN, INC. 16020 INDUSTRIAL DR. Gaithersburg, MD 20877 |
| Contact | Richard Pytelewski |
| Correspondent | Richard Pytelewski IGEN, INC. 16020 INDUSTRIAL DR. Gaithersburg, MD 20877 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-04 |
| Decision Date | 1996-07-31 |