CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT— 510(k) K033105
Substantially EquivalentTrinity Biotech USA
FDA 510(k) clearance K033105 for CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT, Substantially Equivalent on 2004-07-13. Applicant: Trinity Biotech USA.
Clearance details
- Applicant
- Trinity Biotech USA
- Product code
- Code MXJ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jamestown, NY, US
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.