ClearanceBrief
Panels › Clinical Chemistry › Product code JFT · Class 2

Fluorometric, Cortisol

Regulation 862.1205

0510(k)s in 12 months (20 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in JFT

Company510(k)sRecalls
Siemens Healthcare Diagnostics, Inc.23
Roche Diagnostics30
Abbott Laboratories20
Ciba Corning Diagnostics Corp.20
Abbott Laboratories HPD/ADD/GPRD01
Baxter Healthcare Corp10
Bio-Rad Laboratories, Inc.10
Biomerieux Vitek, Inc.10
Fujirebio Diagnostics,Inc.10
Kallestad Diag, A Div. of Erbamont, Inc.10
DateFirm and productCodeLinked 510(k)
May 3, 2023Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use i
Open, Classified		 JFTK962559
May 3, 2023Siemens Healthcare Diagnostics, Inc.
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in
Open, Classified		 JFTK142723
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Terminated		 JFTK954591
Apr 9, 2012Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro
Terminated		 JFTK962559
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Terminated		 JFTK852927
K854419

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