ACCESS PROGESTERONE ASSAY

• K Number: K955769
• Device Name: ACCESS PROGESTERONE ASSAY
• Manufacturer: BIO-RAD LABORATORIES, INC.
• Date Cleared: 1996-02-05 ( 46 days)
• Product Code: JLS
• Regulation Number: 862.1620
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

Regulation Number and Section

§ 862.1620 Progesterone test system.

(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(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.