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K Number
K960066
Device Name
IMMULITE ACTH
Manufacturer
DIAGNOSTIC PRODUCTS CORP.
Date Cleared
1996-02-16

(42 days)

Product Code
CKG
Regulation Number
862.1025
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
K060585
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.

(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.