Atlas FDA

JFT

20 FDA 510(k) clearances · Product code

127 daysmedian time to decision
264 days90th percentile
20clearances measured

FDA profile

Official device name
Fluorometric, Cortisol
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1205
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2012: 16 · 2013: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Elecsys Cortisol III (K242505)Roche Diagnostics2025-07-17
ADVIA Centaur Cortisol (COR) (K192788)Siemens Healthcare Diagnostics, Inc.2019-11-25
Elecsys Cortisol II, Cortisol II CalSet (K152227)Roche Diagnostics2016-04-27
ADVIA Centaur Cortisol (COR) Assy (K142723)Siemens Healthcare Diagnostics, Inc.2015-03-31
ARCHITECT CORTISOL ASSAY (K062204)Seradyn, Inc.2006-09-22
AXSYM CORTISOL ASSAY (K033731)Fujirebio Diagnostics,Inc.2004-02-20
ELECSYS CORTISOL TEST SYSTEM (K021218)Roche Diagnostics Corp.2002-09-09
ACS CORTISOL IMMUNOASSAY (K962559)Ciba Corning Diagnostics Corp.1996-11-05
AIA-PACK CORT ASSAY (K954591)Tosoh Medics, Inc.1995-12-15
CIDBA CORNING ACS CORTISOL IMMUNOASSAY (K934317)Ciba Corning Diagnostics Corp.1994-05-13
DELFIA CORTISOL KIT (K930732)Wallac OY1993-07-27
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT (K931031)Biomerieux Vitek, Inc.1993-07-27
ACCESS(R) CORTISOL REAGENTS (K926322)Bio-Rad Laboratories, Inc.1993-05-26
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR (K900010)Kallestad Diag, A Div. of Erbamont, Inc.1990-04-03
CORTISOL TEST SYSTEM (K895421)Baxter Healthcare Corp1989-12-07
CEDIA CORTISOL ASSAY (K893954)Microgenics Corp.1989-10-31
DELFIA(TM) CORTISOL KIT (K863422)Lkb Instruments, Inc.1986-09-26
TDX CORTISOL (K854419)Abbott Laboratories1985-11-25
TDX CORTISOL (K852927)Abbott Laboratories1985-08-05
SYVA ADVANCE CORTISOL ASSAY (K833932)Syva Co.1983-12-29

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Every clearance here is in the API, with alerts when new ones post.