TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP— 510(k) K950342
Substantially EquivalentBecton Dickinson Immunocytometry Systems
FDA 510(k) clearance K950342 for TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP, Substantially Equivalent on 1996-02-20. Applicant: Becton Dickinson Immunocytometry Systems.
Clearance details
- Applicant
- Becton Dickinson Immunocytometry Systems
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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.