SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS— 510(k) K953598

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K953598 for SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS, Substantially Equivalent on 1996-03-11. Applicant: Serono Diagnostics, Inc..

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1995-08-01
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.