Product Code: KRZ FDA class 2 21 CFR 864.8165

Calibrator For Hemoglobin And Hematocrit Measurement

Hematology

This device is a calibrator used to standardize hematology analyzers for hemoglobin concentration and hematocrit measurements, ensuring accuracy in the assessment of anemia and blood oxygen-carrying capacity. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRZ, regulated under 21 CFR 864.8165 within the Hematology specialty. No special flags apply.

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FEI Numbers

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Basic Information

Product Code: KRZ
Device Class: FDA class 2
Regulation Number: 864.8165
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K052101	C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C	Aug 26, 2005	Substantially Equivalent	Roche Diagnostics
K041130	CDS HEMATOLOGY CALIBRATOR (CDS CAL)	Jun 10, 2004	Substantially Equivalent	Clinical Diagnostic Solutions, Inc.
K962864	THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS	Dec 18, 1996	Substantially Equivalent	Alko Diagnostic Corp.
K951071	ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS	Jul 24, 1995	Substantially Equivalent	Alko Diagnostic Corp.
K902892	CELL-DYN CALIBRATOR	Sep 10, 1990	Substantially Equivalent	Unipath , Ltd.
K896921	RAICHEM TM HEMOGLOBIN CALIBRATOR	Jan 25, 1990	Substantially Equivalent	Reagents Applications, Inc.
K893984	HGB-CAL SET/MULTIPLE	Aug 15, 1989	Substantially Equivalent	R&D Systems, Inc.
K883851	MSI-CAL 8	Nov 22, 1988	Substantially Equivalent	Medical Specialties, Inc.
K883850	MSI-CAL 16	Nov 22, 1988	Substantially Equivalent	Medical Specialties, Inc.
K883703	MSI-CAL 7	Nov 22, 1988	Substantially Equivalent	Medical Specialties, Inc.
K882600	HEMOCUE HEMOGLOBIN CALIBRATOR	Jul 18, 1988	Substantially Equivalent	React and Co.
K873832	REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801	Nov 23, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K871283	CYANMETHEMOGLOBIN STANDARD	Apr 15, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K854166	HEMATOLOGY CALIBRATOR CONTROL	Mar 12, 1986	Substantially Equivalent	Interscience Diagnostics, Inc.
K842668	LIQUI-HEME HEMOGLOBIN CALIBRATORS	Mar 05, 1985	Substantially Equivalent	Biodiagnostic Intl
K843695	QCA HEMOGLOBIN KIT	Dec 17, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K840010	DADE HEMATOLOGY CALIBRATOR PLUS	Apr 19, 1984	Substantially Equivalent	American Dade
K840261	CAL-CHEX, A HEMATOLOGY CALIBRATOR	Feb 21, 1984	Substantially Equivalent	Streck Laboratories, Inc.
K831814	CALIBRATION STANDARD-HEMOGLOBIN	Jul 28, 1983	Substantially Equivalent	United Diagnostics, Inc.
K831872	CALIBRATOR 282	Jul 18, 1983	Substantially Equivalent	Bionostics, Inc.
K831306	HEMACAL	Jun 16, 1983	Substantially Equivalent	Hematology Marketing Assoc.
K822327	CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT	Nov 16, 1982	Substantially Equivalent	Interscience, Inc.
K822046	SERALYZER HEMOGLOBIN CALIBRATORS	Jul 30, 1982	Substantially Equivalent	Miles Laboratories, Inc.
K800852	HEMESPEC CHECK SET	May 02, 1980	Substantially Equivalent	Helena Laboratories
K792358	SANDARE CYANMETHEMOGLOBIN STANDARD	Dec 31, 1979	Substantially Equivalent	Sandare Chemical Co., Inc.