The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Aptima Bv Assay.
| Device ID | K190452 |
| 510k Number | K190452 |
| Device Name: | Aptima BV Assay |
| Classification | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| 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 | PQA |
| Subsequent Product Code | NSU |
| Subsequent Product Code | PMN |
| CFR Regulation Number | 866.3975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045512054 | K190452 | 000 |
| 15420045512047 | K190452 | 000 |
| 15420045512030 | K190452 | 000 |
| 15420045512023 | K190452 | 000 |