CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER— 510(k) K913305

Name: FDA 510(k) clearance K913305
Creator: U.S. Food and Drug Administration
Published: 1991-11-22

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K913305 for CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER, Substantially Equivalent on 1991-11-22. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Product code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1991-07-25
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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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.