CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER— 510(k) K951496
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K951496 for CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER, Substantially Equivalent on 1995-10-19. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, TX, 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.