The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Aptima Assay For Chlamydia Trachomatis, Model 1088.
| Device ID | K053446 |
| 510k Number | K053446 |
| Device Name: | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 |
| Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Contact | Brian J Shea |
| Correspondent | Brian J Shea GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Product Code | MKZ |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-12 |
| Decision Date | 2006-07-25 |
| Summary: | summary |