FDA Device Intelligence
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

RAPIDPOINT® 350 Reagent Module — Siemens Healthcare Diagnostics Inc.Disposable Waste Container D512 REF 905-590 — Radiometer Medical ApSDaily Cleaning Solution Kit — MEDICA CORPORATIONUltraCrit — SEPARATION TECHNOLOGY, INC.RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONUltraCrit Cuvettes — SEPARATION TECHNOLOGY, INC.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONCalibration Solution — Radiometer Medical ApSUltraCrit QC Cuvettes — SEPARATION TECHNOLOGY, INC.UltraCrit (Refurbished) — SEPARATION TECHNOLOGY, INC.Stat Profile — NOVA BIOMEDICAL CORPORATIONRAPIDPOINT® 340 Sampler Module — Siemens Healthcare Diagnostics Inc.RAPIDPOINT® 340/350 pO2 Electrode — Siemens Healthcare Diagnostics Inc.UltraCrit Loaner — SEPARATION TECHNOLOGY, INC.RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics Inc.RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit — Siemens Healthcare Diagnostics Inc.RAPIDPOINT®340/350 pCO2 Electrode — Siemens Healthcare Diagnostics Inc.RAPIDPOINT® 340 Sensor Module — Siemens Healthcare Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONRAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATION

Recent recalls

DateFirmReason
2005-05-24Radiometer America IncThe package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.