FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 1 results

510(k) Data Aggregation

K Number

Device Name

AMUKIN D

Manufacturer

AMUCHINA INTL., INC.

Date Cleared

2000-01-10

(209 days)

Product Code

LIF

Regulation Number

876.5820

Why did this record match?

Applicant Name (Manufacturer) :

AMUCHINA INTL., INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Amukin-D is a chlorine-based, high-level disinfectant for reprocessing hemodialyzers.

Device Description

Amukin-D is a chlorine-based, high-level disinfectant for reprocessing hemodialyzers.

Ask a Question

Page 1 of 1