ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT— 510(k) K933878

Name: FDA 510(k) clearance K933878
Creator: U.S. Food and Drug Administration
Published: 1995-11-14

Substantially Equivalent

Intracel Corp.

FDA 510(k) clearance K933878 for ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT, Substantially Equivalent on 1995-11-14. Applicant: Intracel Corp.. Device class: 2.

Clearance details

Applicant: Intracel Corp.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1993-08-09
Decision date: 1995-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.