The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Pace System Urine Screen.
| Device ID | K892216 |
| 510k Number | K892216 |
| Device Name: | GEN-PROBE PACE SYSTEM URINE SCREEN |
| Classification | Kit, Screening, Urine |
| 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 | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-09-15 |