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Panels › Clinical Chemistry › Product code JKC · Class 1

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Regulation 862.1245

0510(k)s in 12 months (28 all time)
2recalls in 12 months (7 all time)
1recalls that name a 510(k)
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Top companies in JKC

Company510(k)sRecalls
Diagnostic Systems Laboratories, Inc.70
Diagnostic Products Corp.40
Beckman Coulter, Inc.11
GET TESTED INTERNATIONAL AB02
Nichols Institute20
Siemens Healthcare Diagnostics, Inc02
Wien Laboratories, Inc.20
Abbott Gmbh & Co. KG01
Biotecx Laboratories, Inc.10
Cambridge Medical Technology10
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Fructose Intolerance Test
Open, Classified		 JKCNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
DHEA Test
Open, Classified		 JKCNone listed
May 4, 2018Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur DHEA-SO4
Terminated		 JKCNone listed
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
Terminated		 JKCNone listed
Dec 14, 2017Abbott Gmbh & Co. KG
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plas
Terminated		 JKCNone listed
Dec 11, 2012Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sul
Terminated		 JKCNone listed
Jul 26, 2011Beckman Coulter Inc.
DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.
Terminated		 JKCK921534

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