ADVIA Centaur Herpes-2 IgG
FDA 510(k) clearance K181334 · decided 2018-08-23
Clearance details
- K-number
- K181334
- Device name
- ADVIA Centaur Herpes-2 IgG
- Applicant
- Biokit, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-21
- Decision date
- 2018-08-23
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- MYF
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lliça D'Amunt, ES
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 recall (Z-1274-2021) | Siemens Healthcare Diagnostics, Inc | 2021-03-18 |