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510(k) BK130001

Device
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Applicant
Arlington Scientific, Inc.
510(k) number
BK130001
Product code
JQT  
Decision
Substantially Equivalent (SE)
Decision date
2014-02-24
Date received
2013-01-23
Regulation
862.2400
Classification name
Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Medical specialty
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Review panel
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Clearance type
510(k) Traditio
Third party reviewed
No

Other 510(k) Records For Product Code JQT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111356ASIMANAGER - ATArlington Scientific, Inc.2011-11-09
K944185ISOSCANIsolab, Inc.1994-11-17
K915332MODEL 795 FLUOROMETER/DENSITOMETERCiba Corning Diagnostics Corp.1992-02-18
K885254TARGET READERV-Tech, Inc.1989-01-27
K860645ELECTROPHORESIS DATA CENTER (EDC)Helena Laboratories1986-12-17
K862956ICON READERHybritech, Inc.1986-08-19
K853734APOLLO DENSITOMETERAstral Medical Systems1985-09-25
K851154ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18Astral Medical Systems1985-05-13
K850617CORNING 780 FLUOROMETER/DENSITOMETERCorning Medical & Scientific1985-03-12
K850260GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETERGelman Sciences, Inc.1985-02-27
K842313ELVI 146 SEROSCANLogos Scientific, Inc.1984-09-10
K842056ELVI 165 PROTEO SEROSKOPLogos Scientific, Inc.1984-06-22
K810619710 FLUOROMETER/DENSITOMETERCorning Medical & Scientific1981-03-27
K803240CORNING 760 FLUOROMETER/DENSITOMETERTransidyne General Corp.1981-01-09
K780901AUTOMATED ELECTROPHORESIS SYSTEMOlympus Corp.1978-06-28

Legacy Summary#

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FDA Review#

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