Atlas FDA

CGR

84 FDA 510(k) clearances · Product code

42 daysmedian time to decision
136 days90th percentile
84clearances measured

FDA profile

Official device name
Radioimmunoassay, Cortisol
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1205
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
Access Cortisol; DxC 500i Clinical Analyzer (K242190)Beckman Coulter, Inc.2025-03-05
Access Cortisol (K223038)Beckman Coulter, Inc.2023-02-08
IDS Cortisol (K202136)Immunodiagnostic Systems , Ltd.2021-04-13
IMMULITE® 2000 Cortisol (K202826)Siemens Healthcare Diagnostics Products, Ltd.2021-01-15
IMMULITE/IMMULITE® 1000 Cortisol (K203270)Siemens Healthcare Diagnostics Products, Ltd.2021-01-15
CORTISOL ELISA (K062626)Ibl-Hamburg GmbH2006-12-20
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS (K060480)Ortho-Clinical Diagnostics2006-07-03
IBL CORTISOL LIA TEST KIT (K052359)Lehnus & Associates Consulting2005-10-03
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K050202)Beckman Coulter, Inc.2005-02-09
NICHOLS ADVANTAGE CORTISOL (K042689)Nichols Institute Diagnostics2004-12-09
CORTISOL LIA (K010790)Kmi Diagnostics, Inc.2002-01-29
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 (K984520)Nichols Institute Diagnostics1999-02-05
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY (K983990)Ortho-Clinical Diagnostics, Inc.1998-12-29
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT (K962208)Nichols Institute Diagnostics1997-04-08
ACCESS CORTISOL ASSAY (MODIFICATION) (K954733)Bio-Rad Laboratories, Inc.1995-12-05
CIBA CORNING ACS CORTISOL IMMUNOASSAY (K945367)Ciba Corning Diagnostics Corp.1995-05-05
ACE CEDIA CORTISOL ASSAY (K943427)Schiapparelli Biosystems, Inc.1994-11-28
ACCESS CORTISOL REAGENTS (K940221)Bio-Rad Laboratories, Inc.1994-04-26
SYNELISA CORTISOL (K931177)Elias U.S.A., Inc.1993-09-27
IMMULITE CORTISOL (K931409)Diagnostic Products Corp.1993-05-11
CORTISOL CHEMILUMINESCENCE ASSAY (K922676)Nichols Institute1992-07-10
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (K914886)Serono-Baker Diagnostics, Inc.1992-03-02
UBI MAGIWEL CORTISOL QUANTITATIVE (K905473)United Biotech, Inc.1991-01-31
SEROZYME CORTISOL TEST KIT (K903975)Serono-Baker Diagnostics, Inc.1991-01-23
ENZYMUN TEST(R) CORTISOL (K900485)Boehringer Mannheim Corp.1990-05-02
CEDIA (TM) CORTISOL ASSAY (K901296)Microgenics Corp.1990-04-03
MODIFIED CEDIA(TM) CORTISOL ASSAY (K896451)Microgenics Corp.1989-12-12
MILENIA(TM) CORTISOL (MKCO1,5) (K895006)Diagnostic Products Corp.1989-10-23
CORTISOL CLASP-BEAD EIA KIT (K895407)Biotecx Laboratories, Inc.1989-10-19
DSL 7800 ACTIVE CORTISOL (K884689)Diagnostic Systems Laboratories, Inc.1989-02-23
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT (K880687)Amersham Corp.1988-03-24
CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (K870969)Canadian Bioclinical, Ltd.1987-06-22
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT (K872177)Nuclear Diagnostics, Inc.1987-06-17
PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT (K862336)Pantex, Div. Bio-Analysis, Inc.1986-09-25
RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL (K862871)Cambridge Medical Technology1986-08-19
CORTISOL SYSTEM BY EIA (K852939)American Bioclinical, Inc.1985-08-02
ACTIVE CORTISOL DSL 2000-SP (K850141)Diagnostic Systems Laboratories, Inc.1985-02-06
SOPHEIA/MP CORTISOL EIA KIT (K850008)Diagnostic Products Corp.1985-02-01
LEECO CORTISOL-QUANT (K843384)Leeco Diagnostics, Inc.1984-09-28
STRATUS CORTISOL FLUOROMETRIC ENZYME (K843183)American Dade1984-09-17
CORITSOL PREMIX RIA KIT (K842957)Biotecx Laboratories, Inc.1984-09-14
CORNING MAGIC CORTISOL RADIOIMMUNO (K841641)Corning Medical & Scientific1984-09-04
CORTI-COTE CORTISOL SOLID PHASE RADIO (K842365)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-16
AMER. BIO-SCIENCE LAB CORTISOL REAGENT (K842455)American Bio-Science Laboratories1984-08-16
IMMPULSE CORTISOL ASSAY REAGENTS (K842554)Aktis Corp.1984-08-12
NML CORTISOL RIA (K840466)Nuclear Medical Laboratories, Inc.1984-03-30
PHASE II CORTISOL KIT (K834219)Medical & Scientific Designs, Inc.1984-02-04
CORTISOL RADIOIMMUNOASSAY KIT (K832638)Bioclinical Group1983-09-12
EMIT SRD MANUAL CORTISOL ASSAY (K831141)Syva Co.1983-05-27
CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK (K830563)Sorin Biomedica, Fiat, USA, Inc.1983-05-13
CORTISOL KIT (K830148)Cambridge Medical Technology1983-02-09
CORTISOL RIA KIT (K822892)Antibodies, Inc.1982-11-01
SOPHEIA CORTISOL EIA KIT (K822845)Diagnostic Products Corp.1982-10-27
ZETA-CORT (K821931)Amf Biological and Diagnostics Co.1982-07-22
DSL 1020 (K821068)Diagnostic Systems Laboratories, Inc.1982-05-05
CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT (K820341)E. R. Squibb & Sons, Inc.1982-03-04
CORTISOL (RIA) KIT (K820074)Immuno Assay Corp.1982-01-28
COAT-A-COUNT CORTISOL RIA KIT (K810891)Diagnostic Products Corp.1981-04-14
ENDAB CORTISOL KIT (K810192)Immunotech Corp.1981-02-06
CORTI-SHURE (K810033)Nuclear Medical Laboratories, Inc.1981-01-21
CORTISOL 125-I RADIOIMMUNOASSAY KIT (K802969)Ria Products, Inc.1981-01-02
ARIA II 125 I CORTISOL (K802380)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-31
CORTISOL125 RADIOIMMUNOASSAY (K802036)Corning Medical & Scientific1980-10-23
CORTISOL RADIOIMMUNOASSAY KIT (K801203)Technia Diagnostics , Ltd.1980-06-09
GAMMA STICK CORTISOL RIA KIT/STICK KIT (K800538)Alpha Gamma Laboratory1980-04-24
AMERLEX CORTISOL RIA KIT (K800700)Amersham Corp.1980-04-16
VENTRE/SEP CORTISOL RIA (K800594)Ventrex Laboratories, Inc.1980-04-04
EMIT AUTO CORTISOL ASSAY (K800245)Syva Co.1980-03-03
QUANTIMUNE CORTISOL RIA CORTISOL RADIO- (K800045)Bio-Rad1980-01-23
ANALYTE CORTISOL (K792439)Technicon Instruments Corp.1980-01-17
CENTRIA CORTISOL RIA TEST SET (K792243)Ventrex Laboratories, Inc.1979-12-06
CORTISOL RADIOIMMUNOASSAY SYSTEM (K792036)Radioimmunoassay, Inc.1979-10-30
CORTI-SHURE (K791700)Nuclear Medical Laboratories, Inc.1979-10-01
CORALENT COAT 125I CORTISOL RADIOIMM. (K791835)Radioassay Systems Laboratories, Inc.1979-09-27
AUTOPAK CORTISOL TEST DELIVERY SYSTEM (K790906)Micromedic Systems1979-06-27
CORTISOL RIA KIT (K790268)E. R. Squibb & Sons, Inc.1979-04-04
RIA KIT, RIANEN CORTISOL (K782110)New England Nuclear1979-01-26
RIA KIT, QUANTITOPE CORTISOL (K781903)Kallestad Laboratories, Inc.1979-01-26
RIA, CORTISOL KIT (K781730)Radioassay Systems Laboratories, Inc.1978-11-22
CENTRIA CORTISOL RIA (K780725)Union Carbide Corp.1978-06-06
CENTRIA CORTISOL RIA (K771117)Clinical Diagnostics, Inc.1977-06-23
RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) (K761346)New England Nuclear1977-01-07
CORTISOL REAGENT SYSTEM (K760939)Beckman Instruments, Inc.1976-11-16
TEST SYSTEM, RIA CORTISOL (K760256)Corning Medical & Scientific1976-08-11

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