Product Code: GKJ FDA class 1 21 CFR 864.5850

Spinner, Slide, Automated

Hematology

Spinner, Slide, Automated (product code GKJ) is a laboratory device used to automatically prepare blood smears by spinning a drop of blood on a glass microscope slide at a controlled speed, producing thin, evenly distributed monolayer smears for hematology morphology examination. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.5850 in the Hematology specialty (HE), this device carries no special regulatory flags.

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Basic Information

Product Code: GKJ
Device Class: FDA class 1
Regulation Number: 864.5850
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 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K854962	MICRO-MAT SYSTEM	Dec 23, 1985	Substantially Equivalent	Ulster Scientific, Inc.
K854121	MICRO-MAT SYSTEM	Oct 31, 1985	Substantially Equivalent	Prevo Micro-Mat System
K831558	E-Z PREP	Jun 16, 1983	Substantially Equivalent	Coulter Electronics, Inc.
K811534	HEMASPINNER	Aug 18, 1981	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K771898	AUTOMATED SLIDE SPINNER	Oct 18, 1977	Substantially Equivalent	Dynatech Cryomedical Co.
K760007	BLOOD-SMEARING INSTRUMENT (MINIPREP TM)	Sep 03, 1976	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.