IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

• K Number: K011505
• Device Name: IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
• Manufacturer: DIAGNOSTIC PRODUCTS CORP.
• Date Cleared: 2001-07-02 ( 47 days)
• Product Code: CEW
• Regulation Number: 862.1545
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: K013566

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 862.1545 Parathyroid hormone test system.

(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.