510(k) K190452
- Device
- Aptima BV Assay
- Applicant
- Hologic, Inc.
- 510(k) number
- K190452
- Product code
- PQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-23
- Date received
- 2019-02-25
- Regulation
- 866.3975
- Classification name
- Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jeffrey Hergesheimer
- Address
- 10210 Genetic Center Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 1119779
- 2243471
- 3002444944
- 2024800
- 3007420875
- 3016838963
- 3004530258
Source Documents#
Other 510(k) Records For Product Code PQA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243725 | BD Vaginal Panel | Becton, Dickinson and Company | 2024-12-19 |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Hologic, Inc. | 2024-11-25 |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Cepheid | 2023-10-19 |
| K223653 | BD Vaginal Panel | Becton, Dickinson and Company | 2023-03-06 |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022-06-07 |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022-02-09 |
| K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 |
| K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 |
| K190472 | Aptima CV/TV Assay | Hologic, Inc. | 2019-05-16 |
| DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 |
Legacy Summary#
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FDA Review#
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