QKM

A Chemical Vapor Sterilization Multivariable Chemical Indicator

Product code

QKM

Device name

A Chemical Vapor Sterilization Multivariable Chemical Indicator

Device class

Class 2

21 CFR

21 CFR 880.2800

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-05.