Product Code: GKR FDA class 2 21 CFR 864.5620

System, Hemoglobin, Automated

Hematology

System, Hemoglobin, Automated (product code GKR) is an automated instrument system used to measure total hemoglobin concentration in blood samples using photometric or electrochemical methods, providing rapid and standardized results for anemia screening and monitoring in clinical laboratories. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5620 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.

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FEI Numbers

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Basic Information

Product Code: GKR
Device Class: FDA class 2
Regulation Number: 864.5620
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201217	HemoCue Hb 301 System	Aug 04, 2020	Substantially Equivalent	Hemocue AB
K200909	Hemo Control (optional Add Pack Hemo Control DM)	Jun 12, 2020	Substantially Equivalent	Ekf-Diagnostic GmbH
K181751	HemoCue Hb 801 System	Feb 01, 2019	Substantially Equivalent	Hemocue AB
K182298	hemochroma PLUS System	Nov 16, 2018	Substantially Equivalent	Immunostics Inc.,
K172173	DiaSpect Tm, DiaSpect Tm Cuvettes	Apr 06, 2018	Substantially Equivalent	Ekf-Diagnostic GmbH
K163465	hemochroma PLUS System	Sep 08, 2017	Substantially Equivalent	Immunostics Inc.,
K122553	MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM	Aug 05, 2013	Substantially Equivalent	ACON Laboratories, Inc.
K121752	AVIE TOTAL HB TEST SYSTEM	Jan 07, 2013	Substantially Equivalent	Mec Dynamics Corp
K110393	EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W	Mar 04, 2011	Substantially Equivalent	Ekf-Diagnostic GmbH
K090093	STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM	Jun 10, 2009	Substantially Equivalent	Stanbio Laboratory
K081719	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM	Jul 18, 2008	Substantially Equivalent	Stanbio Laboratory
K061047	HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801	Jun 08, 2006	Substantially Equivalent	Hemocue AB
K041234	HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM	Jun 10, 2004	Substantially Equivalent	Hemocue, Inc.
K032482	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM	Oct 24, 2003	Substantially Equivalent	Stanbio Laboratory
K031898	EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM	Sep 24, 2003	Substantially Equivalent	Ekf Diagnostic GmbH
K032203	HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704	Aug 25, 2003	Substantially Equivalent	Hemocue, Inc.
K023561	ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM	Jan 31, 2003	Substantially Equivalent	International Technidyne Corp.
K020710	BIOTEST HEMOGLOBIN MEASURING SYSTEM	Aug 14, 2002	Substantially Equivalent	Biotest Medizintechnik GmbH
K020616	BAYER RAPIDPOINT 405 SYSTEM	Jul 17, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K961312	HEMOCUE B-HEMOGLOBIN SYSTEM	Sep 24, 1996	Substantially Equivalent	Hemocue, Inc.
K945677	IL682, CO-OXIMETER	Oct 20, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K954018	AVL OMNI ANALYZER	Oct 05, 1995	Substantially Equivalent	Avl Scientific Corp.
K910745	HEMOGLOBIN REAGENT	Jul 11, 1991	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K880353	CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM	Jun 15, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K870210	CLEARVIEW CW-10	Apr 28, 1987	Substantially Equivalent	Clearview Instruments, Inc.
K865055	DR.BRUNO LANGE MINI-HBA1 PHOTOMETER	Mar 19, 1987	Substantially Equivalent	Diversa Corp.
K850096	LASER-GLOBIN	Mar 29, 1985	Substantially Equivalent	Hematology Marketing Assoc.
K850094	LASER-GLOBIN POWDER	Mar 29, 1985	Substantially Equivalent	Hematology Marketing Assoc.
K841057	HEMOGLOBIN REAGENT SET	Mar 23, 1984	Substantially Equivalent	Medical Specialties, Inc.
K832020	HEMOCUE PHOTOMETER TECHNICAL MANUAL	Oct 28, 1983	Substantially Equivalent	Aktiebolaget Leo Diagnostics
K831618	HEMOGLOBIN REAGENT	Jun 16, 1983	Substantially Equivalent	Omega Medical Diagnostics
K812127	KING DIAGNOSTICS HEMOGLOBIN TEST	Aug 25, 1981	Substantially Equivalent	King Diagnostics, Inc.
K803016	HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.	Dec 30, 1980	Substantially Equivalent	Helena Laboratories
K803015	HEMESPEC II	Dec 30, 1980	Substantially Equivalent	Helena Laboratories
K802266	HGB3 (1:251)	Oct 23, 1980	Substantially Equivalent	R&D Systems, Inc.
K790030	FLUID, RHEMOX-HB LYSING	Feb 08, 1979	Substantially Equivalent	Sysmex Corp.
K781361	HEMOGLOBINOMETER MODEL 720 B	Sep 14, 1978	Substantially Equivalent	Innovative Medical Systems, Inc.
K780829	SYSING AND HEMOGLOBIN REAGENT	Jun 22, 1978	Substantially Equivalent	Harleco
K771789	BLANKING SOLUTION HGB	Oct 07, 1977	Substantially Equivalent	J.T. Baker Chemical Co.