ISOAMP HSV ASSAY
FDA 510(k) clearance K111951 · decided 2011-09-27
Clearance details
- K-number
- K111951
- Device name
- ISOAMP HSV ASSAY
- Applicant
- Biohelix Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-07-08
- Decision date
- 2011-09-27
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- OQO
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sentosa SA201 HSV 1/2 Qualitative PCR Test (K172509) | Vela Diagnostics USA, Inc. | 2018-02-01 |
| Aptima Herpes Simplex Viruses 1 & 2 Assay (K162673) | Hologic, Inc. | 2017-06-15 |
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K150962) | Focus Diagnostics | 2015-08-28 |
| cobas HSV 1 and 2 Test (K150617) | Roche Molecular Systems, Inc. | 2015-06-01 |
| SEEGENE ANYPLEX II HSV-1/2 ASSAY (K142156) | Seegene | 2015-02-13 |
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |
| IMDX HSV-1/2 FOR ABBOTT M2000 (K140198) | Intelligent Medical Devices, Inc. | 2014-05-13 |
| AMIPLIVUE HSV 1&2 ASSAY (K140029) | Quidel Corporation | 2014-03-26 |
| MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT (K111527) | Eragen Biosciences, Inc. | 2011-08-03 |
| BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS (K103798) | Becton, Dickinson & CO | 2011-03-18 |
| MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 (K100336) | Eragen Biosciences | 2010-05-12 |
Recalls involving this device
No recalls on record reference this clearance.