The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Panther Fusion Flu A/b/rsv Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-s Kit, Panther Fusion Specimen Lysis Tubes.
| Device ID | K171963 |
| 510k Number | K171963 |
| Device Name: | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Contact | Ron Domingo |
| Correspondent | Ron Domingo Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045509313 | K171963 | 000 |
| 15420045509283 | K171963 | 000 |
| 15420045509276 | K171963 | 000 |
| 15420045509269 | K171963 | 000 |
| 15420045509252 | K171963 | 000 |
| 15420045509238 | K171963 | 000 |
| 15420045509221 | K171963 | 000 |
| 15420045509214 | K171963 | 000 |