The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Proflu+ Assay.
| Device ID | K153219 |
| 510k Number | K153219 |
| Device Name: | ProFlu+ Assay |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2015-11-20 |
| Summary: | summary |