STATUSFLOW— 510(k) K982231

Clearance details

Applicant

R&D Systems, Inc.

Product code

Code GKZ

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

1998-06-25

Decision date

1998-07-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Minneapolis, MN, US

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• K160606 — BC-5D Hematology Control2016-09-01
• K130962 — R&D 5D RETIC HEMATOLOGY CONTROL2013-07-24
• K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL2011-04-28
• K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL2010-01-29
• K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL2009-10-28

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 →

• Z-2233-2014 — BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.Class III·Terminated·BD Biosciences, Systems & Reagents·20140718

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982231.