CELL-DYN SAPPHIRE SYSTEM— 510(k) K051215

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K051215 for CELL-DYN SAPPHIRE SYSTEM, Substantially Equivalent on 2005-07-21. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2005-05-12
Decision date: 2005-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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.