DeviceClearance

CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A— 510(k) K030408

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K030408 for CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A, Substantially Equivalent on 2003-03-04. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code GKZ
Device class
Class 2
Regulation
21 CFR 864.5220
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Miami, FL, US
Download summary PDFView on FDA.gov ↗

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More clearances from Beckman Coulter, Inc.

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Adverse events under product code GKZ

product code GKZ
Malfunction
1,205
Total
1,205

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K030408

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030408.

Data sourced from openFDA. This site is unofficial and independent of the FDA.