Product Code: GIF FDA class 1 21 CFR 864.8200

Diluent, Blood Cell

Hematology

Diluent, Blood Cell (product code GIF) is a reagent solution used in hematology analyzers and manual techniques to dilute blood samples to an appropriate concentration for accurate counting and characterization of blood cells. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.8200 in the Hematology specialty (HE), this device carries no special regulatory flags.

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FEI Numbers

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Basic Information

Product Code: GIF
Device Class: FDA class 1
Regulation Number: 864.8200
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 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K883990	KVM ISOTONIC DILUENT	Oct 12, 1988	Substantially Equivalent	Kvm Technologies, Inc.
K883989	KVM ISOTONIC FLUSH SOLUTION	Oct 12, 1988	Substantially Equivalent	Kvm Technologies, Inc.
K882490	HYCEL QUICK-LYSING HEMOGLOBIN REAGENT	Jul 25, 1988	Substantially Equivalent	R&D Systems, Inc.
K882267	SYSMEX QUICKLYSER-II (QLS-200A)	Jul 12, 1988	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K881130	CELL-DYN ISOTONIC DILUENT	Mar 31, 1988	Substantially Equivalent	Abbott Diagnostics
K873347	CELL-DYN DIFF. SCREEN ISOTONIC DILUENT	Sep 09, 1987	Substantially Equivalent	Abbott Diagnostics
K851843	OSMOCEL 3	Jul 30, 1985	Substantially Equivalent	Hematology Marketing Assoc.
K851320	SDI PREPAX DILUKIT M.	Jul 05, 1985	Substantially Equivalent	Scientific Distributors, Inc.
K851280	DASS PACK	Jul 05, 1985	Substantially Equivalent	Dass, Inc.
K850239	SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-	Apr 01, 1985	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K850095	LASER-DIL	Mar 29, 1985	Substantially Equivalent	Hematology Marketing Assoc.
K844782	NSI ELT-D DILUTING FLUID 4000ML	Mar 05, 1985	Substantially Equivalent	Nobel Scientific Industries, Inc.
K842929	HAYEM DILUTING FLUID	Sep 07, 1984	Substantially Equivalent	E K Ind., Inc.
K842068	IDI ISOTONIC DILUENT	Jul 02, 1984	Substantially Equivalent	Interscience Diagnostics, Inc.
K841799	CYANOMETHEMOGLOBIN REAGENT	May 31, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K840477	UNITIZED HEMATOLOGY SET 65132/93	Mar 05, 1984	Substantially Equivalent	Emd Chemicals, Inc.
K840041	SDI PREPAX DILUKIT HW	Mar 05, 1984	Substantially Equivalent	Scientific Distributors, Inc.
K833972	QUICK-COUNT HEMATOLOGY REAGENT KIT	Feb 17, 1984	Substantially Equivalent	Seragen Diagnostics, Inc.
K840043	SDI PREPAX DILUKIT CT	Feb 10, 1984	Substantially Equivalent	Scientific Distributors, Inc.
K840038	PREPAX DILUKIT PLUS	Feb 10, 1984	Substantially Equivalent	Scientific Distributors, Inc.
K833443	ISOTONIC BLOOD CELL DILUENT J & S	Nov 03, 1983	Substantially Equivalent	Jasins & Sayles Associates, Inc.
K832116	ATAC 4700 HEMATOLOGY CELL COUNTER	Oct 20, 1983	Substantially Equivalent	Turpen Laboratory Systems, Inc.
K831617	DILUENT	Jun 16, 1983	Substantially Equivalent	Omega Medical Diagnostics
K830188	OSMOCEL +	Mar 01, 1983	Substantially Equivalent	Hematology Marketing Assoc.
K822325	BLOOD CELL DILUENT 78N 1913	Oct 18, 1982	Substantially Equivalent	Interscience, Inc.
K822501	CDL ISOTONIC DILUENT	Sep 17, 1982	Substantially Equivalent	Connecticut Diagnostics, Ltd.
K821683	REAGENT FOR COULTER COUNTER MODEL 5+11	Jun 24, 1982	Substantially Equivalent	Fisher Scientific Co., LLC
K812309	CRYOSAN NORMAL SALINE	Sep 16, 1981	Substantially Equivalent	Cryosan, Inc.
K801357	MODIFIED BLOOD CELL COUNTING & LYSING	Aug 14, 1980	Substantially Equivalent	Coulter Electronics, Inc.
K801346	NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA	Aug 12, 1980	Substantially Equivalent	Nobel Scientific Industries, Inc.
K800180	VARIOUS REAGENTS FOR BLOOD CELL ANALYZER	Mar 19, 1980	Substantially Equivalent	Laboratory Products, Inc.
K790442	ISOTONIC DILUENT	Apr 04, 1979	Substantially Equivalent	Royco Instruments
K790028	DILUENT, CELLENT BLOOD	Feb 15, 1979	Substantially Equivalent	Sysmex Corp.
K781008	ISOTONIC DILUENT	Jun 28, 1978	Substantially Equivalent	Mallinckrodt Critical Care
K780830	ISOTONIC BUFFERED SALINE	Jun 14, 1978	Substantially Equivalent	Harleco
K771787	AZIDE FREE BLOOD DILUTING REAGENT	Oct 07, 1977	Substantially Equivalent	J.T. Baker Chemical Co.
K760129	SALINE, ISOTONIC BUFFERED, AZIDE-FREE	Jul 20, 1976	Substantially Equivalent	Harleco
K760124	AUTO CELL DILUENT	Jul 20, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic