CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI— 510(k) K895917

Name: FDA 510(k) clearance K895917
Creator: U.S. Food and Drug Administration
Published: 1989-12-29

Substantially Equivalent

Coulter Immunology

FDA 510(k) clearance K895917 for CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI, Substantially Equivalent on 1989-12-29. Applicant: Coulter Immunology. Device class: 2.

Clearance details

Applicant: Coulter Immunology
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1989-10-10
Decision date: 1989-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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K922744 — CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD11993-02-05
K922745 — CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD11993-02-05
K910473 — CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC1991-10-31
K911793 — COULTERCLONE1991-07-09
K893852 — COULTER CLONE T4 MONOCLONAL ANTIBODY1990-03-02

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.