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510(k) K152227

Device
Elecsys Cortisol II, Cortisol II CalSet
Applicant
ROCHE DIAGNOSTICS
510(k) number
K152227
Product code
JFT  
Decision
Substantially Equivalent (SESE)
Decision date
2016-04-27
Date received
2015-08-07
Regulation
862.1205
Classification name
Fluorometric, Cortisol
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KELLI TURNER
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JFT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242505Elecsys Cortisol IIIRoche Diagnostics2025-07-17
K192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc.2019-11-25
K142723ADVIA Centaur Cortisol (COR) AssySiemens Healthcare Diagnostics, Inc.2015-03-31
K062204ARCHITECT CORTISOL ASSAYSeradyn, Inc.2006-09-22
K033731AXSYM CORTISOL ASSAYFujirebio Diagnostics,Inc.2004-02-20
K021218ELECSYS CORTISOL TEST SYSTEMRoche Diagnostics Corp.2002-09-09
K962559ACS CORTISOL IMMUNOASSAYCiba Corning Diagnostics Corp.1996-11-05
K954591AIA-PACK CORT ASSAYTosoh Medics, Inc.1995-12-15
K934317CIDBA CORNING ACS CORTISOL IMMUNOASSAYCiba Corning Diagnostics Corp.1994-05-13
K930732DELFIA CORTISOL KITWallac OY1993-07-27
K931031VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENTBiomerieux Vitek, Inc.1993-07-27
K926322ACCESS(R) CORTISOL REAGENTSBio-Rad Laboratories, Inc.1993-05-26
K900010NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATORKallestad Diag, A Div. of Erbamont, Inc.1990-04-03
K895421CORTISOL TEST SYSTEMBaxter Healthcare Corp1989-12-07
K893954CEDIA CORTISOL ASSAYMicrogenics Corp.1989-10-31

Legacy Summary#

summary

FDA Review#

Decision Summary