The following data is part of a premarket notification filed by Biovation, Inc. with the FDA for Lyris 100/120 Laboratory Information System.
| Device ID | K923844 |
| 510k Number | K923844 |
| Device Name: | LYRIS 100/120 LABORATORY INFORMATION SYSTEM |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | BIOVATION, INC. 875ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Edwin O Brown |
| Correspondent | Edwin O Brown BIOVATION, INC. 875ALFRED NOBEL DR. Hercules, CA 94547 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-31 |
| Decision Date | 1992-12-11 |