CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY— 510(k) K852371

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K852371 for CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY, Substantially Equivalent on 1985-09-17. Applicant: Abbott Diagnostics.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1985-06-04
Decision date: 1985-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.