The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe (r) Luminometer - Leader (tm).
| Device ID | K872219 |
| 510k Number | K872219 |
| Device Name: | GEN-PROBE (R) LUMINOMETER - LEADER (TM) |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Bruni, Ph.d. |
| Correspondent | Bruni, Ph.d. 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 | 1987-06-12 |
| Decision Date | 1987-08-21 |