ABACUS 5— 510(k) K112755

Name: FDA 510(k) clearance K112755
Creator: U.S. Food and Drug Administration
Published: 2012-03-27

Substantially Equivalent

Diatron U.S., Inc.

FDA 510(k) clearance K112755 for ABACUS 5, Substantially Equivalent on 2012-03-27. Applicant: Diatron U.S., Inc.. Device class: 2.

Clearance details

Applicant: Diatron U.S., Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2011-09-21
Decision date: 2012-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, 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 →

Recalls naming K112755

K-number listed on FDA's recall record

Z-0723-2017 — ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20161021

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112755.

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