Cleared Special

K032203 - HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704

K032203 is an FDA 510(k) clearance for HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE..., manufactured by Hemocue, Inc.. The device is a Class 2 Hematology device with product code GKR cleared through the Special 510(k) pathway after a 38-day FDA review.

K032203 · Hemocue, Inc. · Hematology device
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Aug 2003
Decision
38d
Days
Class 2
Risk

K032203 is an FDA 510(k) clearance for the HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Hemocue, Inc. (Potomac, US). The FDA issued a Cleared decision on August 25, 2003 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032203

510(k) Number K032203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2003
Decision Date August 25, 2003
Days to Decision 38 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 113d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

GKR Device Classification - Class 2, Special Controls

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKR System, Hemoglobin, Automated

All 38
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K032203.
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
K041234 · Hemocue, Inc. · Jun 2004
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · Stanbio Laboratory · Oct 2003
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K031898 · Ekf Diagnostic GmbH · Sep 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · International Technidyne Corp. · Jan 2003
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710 · Biotest Medizintechnik GmbH · Aug 2002
BAYER RAPIDPOINT 405 SYSTEM
K020616 · Bayer Diagnostics Corp. · Jul 2002
K032203 · HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
Download PDF Hemocue, Inc.