510(k) K162673
- Device
- Aptima Herpes Simplex Viruses 1 & 2 Assay
- Applicant
- HOLOGIC, INC.
- 510(k) number
- K162673
- Product code
- OQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-15
- Date received
- 2016-09-26
- Regulation
- 866.3305
- Classification name
- Herpes Simplex Virus Nucleic Acid Amplification Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ron Domingo
- Address
- 10210 Genetic Center Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 2024800
- 2023365
- 9610126
- 3004141078
- 3003795116
- 3009875001
- 2243471
Source Documents#
Other 510(k) Records For Product Code OQO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR Test | Vela Diagnostics USA, Inc. | 2018-02-01 |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Focus Diagnostics | 2015-08-28 |
| K150617 | cobas HSV 1 and 2 Test | Roche Molecular Systems, Inc. | 2015-06-01 |
| K142156 | SEEGENE ANYPLEX II HSV-1/2 ASSAY | Seegene | 2015-02-13 |
| K142738 | artus HSV-1/2 QS-RGQ MDx Kit | Qiagen | 2014-12-19 |
| K140198 | IMDX HSV-1/2 FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2014-05-13 |
| K140029 | AMIPLIVUE HSV 1&2 ASSAY | Quidel Corporation | 2014-03-26 |
| K111951 | ISOAMP HSV ASSAY | Biohelix Corporation | 2011-09-27 |
| K111527 | MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT | Eragen Biosciences, Inc. | 2011-08-03 |
| K103798 | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS | Becton, Dickinson & CO | 2011-03-18 |
| K100336 | MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 | Eragen Biosciences | 2010-05-12 |
Legacy Summary#
summary
FDA Review#
Decision Summary