Atlas FDA

CKG

30 FDA 510(k) clearances · Product code

73 daysmedian time to decision
218 days90th percentile
30clearances measured

FDA profile

Official device name
Radioimmunoassay, Acth
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1025
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
IDS ACTH II (K223867)Immunodiagnostic Systems Limited2023-08-18
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 (K111335)Tosoh Bioscience, Inc.2011-12-01
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH (K060585)Roche Diagnostics Corp.2006-05-03
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 (K050748)Scantibodies Laboratory, Inc.2005-05-20
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (K021032)Scantibodies Laboratory, Inc.2002-06-03
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (K002638)Future Diagnostics B.V.2001-01-17
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (K982608)Sangui Biotech, Inc.1998-08-19
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (K962601)Nichols Institute Diagnostics1996-12-24
MICRO HAEMATOCRIT CENTRIFUGE (K960491)Hawksley & Sons , Ltd.1996-10-18
IMMULITE ACTH (K960066)Diagnostic Products Corp.1996-02-16
INCSTAR ACTH IRMA (K940271)Incstar Corp.1994-08-02
ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT (K926396)Nichols Institute1993-07-27
ACTH IRMA KIT II MITSUBISHI YUKA (K915727)Mitsubishi Yuka America, Inc.1992-03-02
ACTH IRMA KIT MITSUBISHI YUKA (K910178)Science Regulatory Services Intl.1991-05-22
MODIFIED DSL-2300 ACTH RIA (K900147)Diagnostic Systems Laboratories, Inc.1990-03-01
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES (K882741)Nichols Institute Diagnostics1988-08-30
ACTHK-PR RIA KIT (K860311)Compagnie Oris Industrie, S.A.1986-04-07
BACI 6 -ADRENOCORTICOTROOP HORMONE (K850053)Euro-Diagnostics BV1985-04-08
ACTH II BY RADIOIMMUNOASSAY (K850882)Immuno Nuclear Corp.1985-03-21
ACTH RIA (K844181)Syncor Intl. Corp.1984-11-27
ACTH NORMAL RANGE (K842249)Diagnostic Systems Laboratories, Inc.1984-08-15
ADRENOCORTICOTROPIC HORMONE TEST (K833934)Clinetics Corp.1984-04-04
DPC ACTH KIT (K840018)Diagnostic Products Corp.1984-03-23
ACTH RIA (K833849)Syncor Intl. Corp.1984-01-30
ADRENOCOR TICOTROPIC HORMONE RADIOIMM (K833471)Nichols Institute Diagnostics1984-01-11
HATCH KIT (K831855)Radioassay Systems Laboratories, Inc.1983-07-28
ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY (K831826)Damon Corp.1983-07-18
ACTH RIA SYSTEM-DSI 2300 (K830893)Diagnostic Systems Laboratories, Inc.1983-04-27
SERAGAN ACTH125 I-RIA KIT (K822115)Seragen Diagnostics, Inc.1982-10-18
ACTH RADIOIMMUNOASSAY KIT (K811565)Immuno Nuclear Corp.1981-06-25

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