ORTHO ELT-8/DS HEMATOLOGY ANALYZER— 510(k) K833618

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K833618 for ORTHO ELT-8/DS HEMATOLOGY ANALYZER, Substantially Equivalent on 1984-01-13. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1983-10-14
Decision date: 1984-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, 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.