Product Code: KHG FDA class 2 21 CFR 864.7500

Whole Blood Hemoglobin Determination

Hematology

Whole Blood Hemoglobin Determination is an in vitro diagnostic device used to measure the concentration of hemoglobin in a whole blood sample, providing essential information for the diagnosis and monitoring of anemia, blood disorders, and overall patient health status. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHG, regulated under 21 CFR 864.7500, within the Hematology medical specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: KHG
Device Class: FDA class 2
Regulation Number: 864.7500
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

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
K221508	AnemoCheck Home	Sep 29, 2023	Substantially Equivalent	Sanguina, Inc.
K163215	AnemoCheck	Sep 13, 2017	Substantially Equivalent	Sanguina, LLC
K042379	ANEMIAPRO SELF-SCREENER	Dec 15, 2004	Substantially Equivalent	Biosafe Laboratories, Inc.
K020138	STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090	Feb 11, 2002	Substantially Equivalent	Gds Technology
K001462	CARESIDE HEMOGLOBIN	Aug 21, 2000	Substantially Equivalent	Careside, Inc.
K994073	HEMOSITE TEST SYSTEM	Jan 14, 2000	Substantially Equivalent	Gds Technology, LLC
K973649	HEMOSITE TEST SYSTEM	Aug 31, 1998	Substantially Equivalent	Gds Technology, LLC
K953221	ABBOTT VISION HEMOGLOBIN (MODIFICATION)	Sep 29, 1995	Substantially Equivalent	Abbott Laboratories
K934064	REFLOTRON HEMOGLOBIN TEST TABS	Dec 06, 1993	Substantially Equivalent	Boehringer Mannheim Corp.
K895101	BIOTRACK HEMOGLOBIN TEST CARTRIDGE	Oct 10, 1989	Substantially Equivalent	Biotrack, Inc.
K885227	CLINISTAT HEMOGLOBIN REAGENT TEST	Feb 24, 1989	Substantially Equivalent	Heraeus Kulzer, Inc.
K880038	FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527	Apr 21, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K872653	EASY-TEST HEMOGLOBIN (HGB) ITEM #16685	Jul 23, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K870363	HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD	Mar 16, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K863104	TOTAL HEMOGLOBIN	Sep 04, 1986	Substantially Equivalent	J. D. Assoc.
K862641	U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)	Aug 21, 1986	Substantially Equivalent	U. S. Diagnostics, Inc.
K862202	VISION(TM) HEMOGLOBIN	Aug 18, 1986	Substantially Equivalent	Abbott Laboratories
K854687	ERMA HB-METER MODEL 303N	Jun 04, 1986	Substantially Equivalent	Future Impex Corp.
K860475	HEMOGLOBIN REAGENT SET	Mar 03, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K854139	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB	Nov 05, 1985	Substantially Equivalent	Eastman Kodak Company
K851467	HEMOGLOBIN ANALYZER	Jul 16, 1985	Substantially Equivalent	Awareness Technology, Inc.
K851432	HEMOGLOBIN	Jul 12, 1985	Substantially Equivalent	Pointe Scientific, Inc.,
K832750	EASYTOUCH HEMOGLOBIN REAGENT	Sep 26, 1983	Substantially Equivalent	Worthington Diagnostic Systems
K831813	CO-OXIMETER CONTROL	Jul 28, 1983	Substantially Equivalent	United Diagnostics, Inc.
K830180	REFEREE BRAND CO-OXIMETER REAGENTS	Apr 08, 1983	Substantially Equivalent	Analytical Products, Inc.
K830590	CORNING 2500 CO-OXIMETER	Apr 05, 1983	Substantially Equivalent	Corning Medical & Scientific
K823060	HEMOGLOBIN REAGENT	Nov 22, 1982	Substantially Equivalent	Biorent Diagnostic, Inc.
K822045	SERALYZER HEMOGLOBIN TEST MODULE	Jul 30, 1982	Substantially Equivalent	Miles Laboratories, Inc.
K822044	SERALYZER HEMOGLOBIN REAGENT STRIPS	Jul 30, 1982	Substantially Equivalent	Miles Laboratories, Inc.
K821658	HEMOGLOBIN REAGENT	Jun 25, 1982	Substantially Equivalent	Anco Medical Reagents & Assoc.
K820596	CYANMETHEMOGLOBIN TEST	Mar 26, 1982	Substantially Equivalent	Boehringer Mannheim Corp.
K803248	AMES SERA-PAK HEMOGLOBIN REAGENT	Jan 26, 1981	Substantially Equivalent	Miles Laboratories, Inc.
K802268	CRC(CYANMETHEMOGLOBIN REAGENT CONCENT	Dec 31, 1980	Substantially Equivalent	R&D Systems, Inc.
K802569	ABNORMAL HEMOGLOBIN CONTROL	Nov 12, 1980	Substantially Equivalent	Marilyn L. Amick
K802568	HEMOGLOBIN CONTROL	Nov 12, 1980	Substantially Equivalent	Marilyn L. Amick
K801268	HEMOGLOBIN CONTROL LEVELS	Jul 14, 1980	Substantially Equivalent	Bioscientific
K800059	COMPUR M-1000 MINI-PHOTOMETER	Apr 04, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K792503	SANDARE CYANMETHEMOGLOBIN REAGENT	Dec 31, 1979	Substantially Equivalent	Sandare Chemical Co., Inc.
K760208	OXIMETER, CO-, IL MODEL 282	Jul 26, 1976	Substantially Equivalent	Instrumentation Laboratory CO