Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) — Hologic, Inc. (510(k) K200866)
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) — Hologic, Inc. (510(k) K200866) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System); Applicant: Hologic, Inc.; Clearance track:
| Device name | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) |
|---|---|
| Applicant | Hologic, Inc. |
| Clearance track | 510(k) |
| Submission number | K200866 |
| Decision | Substantially Equivalent |
| Decision date | 2020-05-17 |
| Date received | 2020-04-01 |
| Product code | QEP |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | CA, US |
| Source | openFDA device |
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