Home › Device types › GKF
Instrument, Hematocrit, Automated
FDA product code GKF · Class 2 · Hematology
66
Registered devices
5
Adverse events
1
Recalls
15
510(k) clearances
Devices with this code
pH/pCO2/pO2/Na/K/Ca Analyzer — MEDICA CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDPOINT® 340/350 pO2 Electrode — Siemens Healthcare Diagnostics Inc.Disposable Waste Container D512 REF 905-590 — Radiometer Medical ApSUltraCrit (Refurbished) — SEPARATION TECHNOLOGY, INC.Calibration Solution — Radiometer Medical ApSUltraChek Reference Controls Low — SEPARATION TECHNOLOGY, INC.RAPIDPOINT® 350 Ca++ Electrode — Siemens Healthcare Diagnostics Inc.Daily Cleaning Solution Kit — MEDICA CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDPOINT® 340 Sampler Module — Siemens Healthcare Diagnostics Inc.RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics Inc.UltraChek Reference Controls Normal — SEPARATION TECHNOLOGY, INC.RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics Inc.Calibration Solution — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDPOINT®340/350 pCO2 Electrode — Siemens Healthcare Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDPOINT® 340/350 Valve Module — Siemens Healthcare Diagnostics Inc.UltraChek Reference Controls High — SEPARATION TECHNOLOGY, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-05-24 | Radiometer America Inc | The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The |
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