Radioimmunoassay, Acth

FDA product code CKG · 30 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1025
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-06-25 – 2023-08-18

CKG 2023-08-18

IDS ACTH II

Applicant Immunodiagnostic Systems Limited

K number K223867

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CKG 2011-12-01

ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321

Applicant Tosoh Bioscience, Inc.

K number K111335

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CKG 2006-05-03

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH

Applicant Roche Diagnostics Corp.

K number K060585

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CKG 2005-05-20

ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011

Applicant Scantibodies Laboratory, Inc.

K number K050748

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CKG 2002-06-03

ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100

Applicant Scantibodies Laboratory, Inc.

K number K021032

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CKG 2001-01-17

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

Applicant Future Diagnostics B.V.

K number K002638

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CKG 1998-08-19

SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT

Applicant Sangui Biotech, Inc.

K number K982608

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CKG 1996-12-24

NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE

Applicant Nichols Institute Diagnostics

K number K962601

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CKG 1996-10-18

MICRO HAEMATOCRIT CENTRIFUGE

Applicant Hawksley & Sons , Ltd.

K number K960491

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CKG 1996-02-16

IMMULITE ACTH

Applicant Diagnostic Products Corp.

K number K960066

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CKG 1994-08-02

INCSTAR ACTH IRMA

Applicant Incstar Corp.

K number K940271

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CKG 1993-07-27

ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT

Applicant Nichols Institute

K number K926396

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CKG 1992-03-02

ACTH IRMA KIT II MITSUBISHI YUKA

Applicant Mitsubishi Yuka America, Inc.

K number K915727

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CKG 1991-05-22

ACTH IRMA KIT MITSUBISHI YUKA

Applicant Science Regulatory Services Intl.

K number K910178

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CKG 1990-03-01

MODIFIED DSL-2300 ACTH RIA

Applicant Diagnostic Systems Laboratories, Inc.

K number K900147

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CKG 1988-08-30

ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES

Applicant Nichols Institute Diagnostics

K number K882741

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CKG 1986-04-07

ACTHK-PR RIA KIT

Applicant Compagnie Oris Industrie, S.A.

K number K860311

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CKG 1985-04-08

BACI 6 -ADRENOCORTICOTROOP HORMONE

Applicant Euro-Diagnostics BV

K number K850053

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CKG 1985-03-21

ACTH II BY RADIOIMMUNOASSAY

Applicant Immuno Nuclear Corp.

K number K850882

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CKG 1984-11-27

ACTH RIA

Applicant Syncor Intl. Corp.

K number K844181

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CKG 1984-08-15

ACTH NORMAL RANGE

Applicant Diagnostic Systems Laboratories, Inc.

K number K842249

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CKG 1984-04-04

ADRENOCORTICOTROPIC HORMONE TEST

Applicant Clinetics Corp.

K number K833934

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CKG 1984-03-23

DPC ACTH KIT

Applicant Diagnostic Products Corp.

K number K840018

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CKG 1984-01-30

ACTH RIA

Applicant Syncor Intl. Corp.

K number K833849

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CKG 1984-01-11

ADRENOCOR TICOTROPIC HORMONE RADIOIMM

Applicant Nichols Institute Diagnostics

K number K833471

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CKG 1983-07-28

HATCH KIT

Applicant Radioassay Systems Laboratories, Inc.

K number K831855

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CKG 1983-07-18

ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY

Applicant Damon Corp.

K number K831826

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CKG 1983-04-27

ACTH RIA SYSTEM-DSI 2300

Applicant Diagnostic Systems Laboratories, Inc.

K number K830893

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CKG 1982-10-18

SERAGAN ACTH125 I-RIA KIT

Applicant Seragen Diagnostics, Inc.

K number K822115

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CKG 1981-06-25

ACTH RADIOIMMUNOASSAY KIT

Applicant Immuno Nuclear Corp.

K number K811565

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