K180681 is an FDA 510(k) clearance for the Aptima Combo 2 Assay (Panther System). This device is classified as a Dna-reagents, Neisseria (Class II - Special Controls, product code LSL).
Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on June 13, 2018, 90 days after receiving the submission on March 15, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K180681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2018 |
| Decision Date | June 13, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSL — Dna-reagents, Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |