TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP; WITH TRUCOUNT ABSOLUTE COUNT TUBES— 510(k) K971110
Substantially EquivalentBecton Dickinson Immunocytometry Systems
FDA 510(k) clearance K971110 for TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP; WITH TRUCOUNT ABSOLUTE COUNT TUBES, Substantially Equivalent on 1997-11-25. Applicant: Becton Dickinson Immunocytometry Systems. Device class: 2.
Clearance details
- Device name as filed
- TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
- Applicant
- Becton Dickinson Immunocytometry Systems
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GKZ
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view allAdverse 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.