The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Panther Fusion Adv/hmpv/rv Assay.
| Device ID | K172629 |
| 510k Number | K172629 |
| Device Name: | Panther Fusion AdV/hMPV/RV Assay |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Contact | Anila K Tarte |
| Correspondent | Anila K Tarte Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Product Code | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2017-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045509320 | K172629 | 000 |
| 15420045509290 | K172629 | 000 |