Product Code: JQT FDA class 1 21 CFR 862.2400

Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

Clinical Chemistry

The Densitometer/Scanner (Integrating, Reflectance, TLC, Radiochromatographic) for Clinical Use is a clinical laboratory instrument used to scan and quantify separated zones on electrophoresis gels, thin-layer chromatography (TLC) plates, or radiochromatographic media by measuring light reflectance or absorption, providing quantitative data on analyte fractions. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQT and is regulated under 21 CFR 862.2400, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JQT
Device Class: FDA class 1
Regulation Number: 862.2400
Medical Specialty: Clinical Chemistry
Review Panel: CH
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 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K111356	ASIMANAGER - AT	Nov 09, 2011	Substantially Equivalent	Arlington Scientific, Inc.
K944185	ISOSCAN	Nov 17, 1994	Substantially Equivalent	Isolab, Inc.
K915332	MODEL 795 FLUOROMETER/DENSITOMETER	Feb 18, 1992	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K885254	TARGET READER	Jan 27, 1989	Substantially Equivalent	V-Tech, Inc.
K860645	ELECTROPHORESIS DATA CENTER (EDC)	Dec 17, 1986	Substantially Equivalent	Helena Laboratories
K862956	ICON READER	Aug 19, 1986	Substantially Equivalent	Hybritech, Inc.
K853734	APOLLO DENSITOMETER	Sep 25, 1985	Substantially Equivalent	Astral Medical Systems
K851154	ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18	May 13, 1985	Substantially Equivalent	Astral Medical Systems
K850617	CORNING 780 FLUOROMETER/DENSITOMETER	Mar 12, 1985	Substantially Equivalent	Corning Medical & Scientific
K850260	GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER	Feb 27, 1985	Substantially Equivalent	Gelman Sciences, Inc.
K842313	ELVI 146 SEROSCAN	Sep 10, 1984	Substantially Equivalent	Logos Scientific, Inc.
K842056	ELVI 165 PROTEO SEROSKOP	Jun 22, 1984	Substantially Equivalent	Logos Scientific, Inc.
K810619	710 FLUOROMETER/DENSITOMETER	Mar 27, 1981	Substantially Equivalent	Corning Medical & Scientific
K803240	CORNING 760 FLUOROMETER/DENSITOMETER	Jan 09, 1981	Substantially Equivalent	Transidyne General Corp.
K780901	AUTOMATED ELECTROPHORESIS SYSTEM	Jun 28, 1978	Substantially Equivalent	Olympus Corp.
K780318	MODULAR SCANNING DENSITOMETER SYS.	Apr 12, 1978	Substantially Equivalent	Transidyne General Corp.
K772325	DENSITOMETER 18, COMPUTING, AUTO.	Jan 12, 1978	Substantially Equivalent	Gelman Instrument Co.
K770026	FLOUROMETER/DENSITOMETER MODEL 720	Jan 26, 1977	Substantially Equivalent	Corning Medical & Scientific