DeviceClearance

ADVIA 2120i, ADVIA 2120— 510(k) K162977

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K162977 for ADVIA 2120i, ADVIA 2120, Substantially Equivalent on 2017-08-11. 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 K162977

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 K162977.

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