FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K960066 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE ACTH |
02/16/1996 |
K002638 |
FUTURE DIAGNOSTICS B.V. |
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT |
01/17/2001 |
K960491 |
HAWKSLEY & SONS LTD. |
MICRO HAEMATOCRIT CENTRIFUGE |
10/18/1996 |
K223867 |
Immunodiagnostic Systems Limited |
IDS ACTH II |
08/18/2023 |
K962601 |
NICHOLS INSTITUTE DIAGNOSTICS |
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE |
12/24/1996 |
K060585 |
ROCHE DIAGNOSTICS CORP. |
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH |
05/03/2006 |
K982608 |
SANGUI BIOTECH, INC. |
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT |
08/19/1998 |
K050748 |
SCANTIBODIES LABORATORY, INC. |
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 |
05/20/2005 |
K021032 |
SCANTIBODIES LABORATORY, INC. |
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 |
06/03/2002 |
K111335 |
Tosoh BioScience, Inc. |
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 |
12/01/2011 |