The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Aptima Combo 2 Assay (panther System).
| Device ID | K190515 |
| 510k Number | K190515 |
| Device Name: | Aptima Combo 2 Assay (Panther System) |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Contact | Jeffrey Hergesheimer |
| Correspondent | Jeffrey Hergesheimer Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2019-05-23 |
| Summary: | summary |