ABACUS 3CP— 510(k) K111534

Substantially Equivalent

Diatron U.S., Inc.

FDA 510(k) clearance K111534 for ABACUS 3CP, Substantially Equivalent on 2012-08-02. Applicant: Diatron U.S., Inc..

Clearance details

Applicant: Diatron U.S., Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2011-06-02
Decision date: 2012-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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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 →

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