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510(k) K223867

Device
IDS ACTH II
Applicant
Immunodiagnostic Systems Limited
510(k) number
K223867
Product code
CKG
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-18
Date received
2022-12-23
Regulation
862.1025
Classification name
Radioimmunoassay, Acth
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
Mick Henderson
Address
10 Didcot Way, Boldon Business Park Boldon GB NE35 9PD NE35 9PD

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CKG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.2011-12-01
K060585ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHRoche Diagnostics Corp.2006-05-03
K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.2005-05-20
K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.2002-06-03
K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KITFuture Diagnostics B.V.2001-01-17
K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITSangui Biotech, Inc.1998-08-19
K962601NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONENichols Institute Diagnostics1996-12-24
K960491MICRO HAEMATOCRIT CENTRIFUGEHawksley & Sons , Ltd.1996-10-18
K960066IMMULITE ACTHDiagnostic Products Corp.1996-02-16
K940271INCSTAR ACTH IRMAIncstar Corp.1994-08-02
K926396ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCTNichols Institute1993-07-27
K915727ACTH IRMA KIT II MITSUBISHI YUKAMitsubishi Yuka America, Inc.1992-03-02
K910178ACTH IRMA KIT MITSUBISHI YUKAScience Regulatory Services Intl.1991-05-22
K900147MODIFIED DSL-2300 ACTH RIADiagnostic Systems Laboratories, Inc.1990-03-01
K882741ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBESNichols Institute Diagnostics1988-08-30