DeviceClearance

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I— 510(k) K102644

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K102644 for ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I, Substantially Equivalent on 2011-11-23. Applicant: Siemens Healthcare Diagnostics. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics
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
Traditional
Location
Tarrytown, NY, US
Download summary PDFView 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, 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 K102644

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 K102644.

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