The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Amplified Chlamydia Trachomatis Assay Kit.
| Device ID | K962217 |
| 510k Number | K962217 |
| Device Name: | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT |
| Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Gerald H Schell |
| Correspondent | Gerald H Schell GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Product Code | MKZ |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-10 |
| Decision Date | 1996-11-27 |
| Summary: | summary |