The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Pace 2 Chlamydia Trachomatis Probe Confirm Assay.
| Device ID | K920302 |
| 510k Number | K920302 |
| Device Name: | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY |
| Classification | Dna-reagents, Chlamydia |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Ruben Chairez |
| Correspondent | Ruben Chairez GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Product Code | LSK |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-21 |
| Decision Date | 1994-04-06 |