The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Luminometer-leader 450.
| Device ID | K905762 |
| 510k Number | K905762 |
| Device Name: | GEN-PROBE LUMINOMETER-LEADER 450 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Connie Kirby |
| Correspondent | Connie Kirby GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-01-23 |