FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K963992

Device Name

CAPILLARY ADAPTOR ACCESSORY

Manufacturer

MEDICA CORP.

Date Cleared

1996-11-29

(56 days)

Product Code

CGZ,CEM,JGS,JIH

Regulation Number

862.1170

Type

Traditional

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Summary

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.