HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST— 510(k) K131334
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K131334 for HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST, Substantially Equivalent on 2014-02-28. Applicant: Gold Standard Diagnostics. Device class: 2.
Clearance details
- Applicant
- Gold Standard Diagnostics
- Product code
- Code MXJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davis, CA, US
Recent devices under product code MXJ
view allMore clearances from Gold Standard Diagnostics
view all- K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
- K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K200023 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Adverse events under product code MXJ
product code MXJ- Injury
- 139
- Total
- 139
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.