The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Pace System For Neisseria Gonorrhoeae Addi. Claims.
| Device ID | K881277 |
| 510k Number | K881277 |
| Device Name: | PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS |
| Classification | Dna-reagents, Neisseria |
| 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 | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-04-25 |