ABACUS 3CP— 510(k) K111534
Substantially EquivalentDiatron U.S., Inc.
FDA 510(k) clearance K111534 for ABACUS 3CP, Substantially Equivalent on 2012-08-02. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Recent devices under product code GKZ
view allMore clearances from Diatron U.S., Inc.
view allAdverse 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 K111534
K-number listed on FDA's recall record- Z-0723-2017 — ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
- Z-1500-2016 — ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111534.
Data sourced from openFDA. This site is unofficial and independent of the FDA.