The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Panther Fusion Paraflu Assay.
| Device ID | K172282 |
| 510k Number | K172282 |
| Device Name: | Panther Fusion Paraflu Assay |
| Classification | Parainfluenza Multiplex Nucleic Acid Assay |
| 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 | OOU |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2017-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045509337 | K172282 | 000 |
| 15420045509306 | K172282 | 000 |