DSL ACTIVE PROLACTIN ELISA MODEL 10-4500

• K Number: K960561
• Device Name: DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
• Manufacturer: DIAGNOSTIC SYSTEMS LABORATORIES, INC.
• Date Cleared: 1996-04-26 ( 77 days)
• Product Code: CFT
• Regulation Number: 862.1625
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 862.1625 Prolactin (lactogen) test system.

(a)
Identification. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.