CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES— 510(k) K060423

Name: FDA 510(k) clearance K060423
Creator: U.S. Food and Drug Administration
Published: 2006-08-15

Substantially Equivalent

Dakocytomation California, Inc.

FDA 510(k) clearance K060423 for CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES, Substantially Equivalent on 2006-08-15. Applicant: Dakocytomation California, Inc.. Device class: 2.

Clearance details

Applicant: Dakocytomation California, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2006-02-17
Decision date: 2006-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, 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.