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K Number
K973898
Device Name
PROGESTERONE ELISA
Manufacturer
KMI DIAGNOSTICS, INC.
Date Cleared
1997-11-13

(30 days)

Product Code
JLS
Regulation Number
862.1620
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IBL Progesterone ELISA test kit is 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.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Progesterone ELISA Test Kit. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Thus, I cannot answer questions 1-9 based on the provided text.

§ 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.