Panels › Clinical Chemistry › Product code CKG · Class 2

Radioimmunoassay, Acth

Regulation 862.1025

0510(k)s in 12 months (30 all time)

3recalls in 12 months (6 all time)

2recalls that name a 510(k)

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Top companies in CKG

Company	510(k)s	Recalls
Nichols Institute Diagnostics	3	1
Diagnostic Systems Laboratories, Inc.	3	0
GET TESTED INTERNATIONAL AB	0	3
Diagnostic Products Corp.	2	0
Immuno Nuclear Corp.	2	0
Scantibodies Laboratory, Inc.	2	0
Syncor Intl. Corp.	2	0
Tosoh Bioscience, Inc.	1	1
Beckman Coulter Inc.	0	1
Clinetics Corp.	1	0

Decided	510(k)	Device and applicant	Code
Aug 18, 2023	K223867	IDS ACTH II Immunodiagnostic Systems Limited, GB	CKG
Dec 1, 2011	K111335	ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 Tosoh Bioscience, Inc.	CKG
May 3, 2006	K060585	ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH Roche Diagnostics Corp.	CKG
May 20, 2005	K050748	ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 Scantibodies Laboratory, Inc.	CKG
Jun 3, 2002	K021032	ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 Scantibodies Laboratory, Inc.	CKG
Jan 17, 2001	K002638	FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT Future Diagnostics B.V.	CKG
Aug 19, 1998	K982608	SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT Sangui Biotech, Inc.	CKG
Dec 24, 1996	K962601	NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE Nichols Institute Diagnostics	CKG
Oct 18, 1996	K960491	MICRO HAEMATOCRIT CENTRIFUGE Hawksley & Sons , Ltd., GB	CKG
Feb 16, 1996	K960066	IMMULITE ACTH Diagnostic Products Corp.	CKG
Aug 2, 1994	K940271	INCSTAR ACTH IRMA Incstar Corp.	CKG
Jul 27, 1993	K926396	ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT Nichols Institute	CKG
Mar 2, 1992	K915727	ACTH IRMA KIT II MITSUBISHI YUKA Mitsubishi Yuka America, Inc.	CKG
May 22, 1991	K910178	ACTH IRMA KIT MITSUBISHI YUKA Science Regulatory Services Intl.	CKG
Mar 1, 1990	K900147	MODIFIED DSL-2300 ACTH RIA Diagnostic Systems Laboratories, Inc.	CKG
Aug 30, 1988	K882741	ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES Nichols Institute Diagnostics	CKG
Apr 7, 1986	K860311	ACTHK-PR RIA KIT Compagnie Oris Industrie, S.A.	CKG
Apr 8, 1985	K850053	BACI 6 -ADRENOCORTICOTROOP HORMONE Euro-Diagnostics BV	CKG
Mar 21, 1985	K850882	ACTH II BY RADIOIMMUNOASSAY Immuno Nuclear Corp.	CKG
Nov 27, 1984	K844181	ACTH RIA Syncor Intl. Corp.	CKG
Aug 15, 1984	K842249	ACTH NORMAL RANGE Diagnostic Systems Laboratories, Inc.	CKG
Apr 4, 1984	K833934	ADRENOCORTICOTROPIC HORMONE TEST Clinetics Corp.	CKG
Mar 23, 1984	K840018	DPC ACTH KIT Diagnostic Products Corp.	CKG
Jan 30, 1984	K833849	ACTH RIA Syncor Intl. Corp.	CKG
Jan 11, 1984	K833471	ADRENOCOR TICOTROPIC HORMONE RADIOIMM Nichols Institute Diagnostics	CKG
Jul 28, 1983	K831855	HATCH KIT Radioassay Systems Laboratories, Inc.	CKG
Jul 18, 1983	K831826	ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY Damon Corp.	CKG
Apr 27, 1983	K830893	ACTH RIA SYSTEM-DSI 2300 Diagnostic Systems Laboratories, Inc.	CKG
Oct 18, 1982	K822115	SERAGAN ACTH125 I-RIA KIT Seragen Diagnostics, Inc.	CKG
Jun 25, 1981	K811565	ACTH RADIOIMMUNOASSAY KIT Immuno Nuclear Corp.	CKG

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