Biological Indicator - Kemmed & Biosure

FDA 510(k) K802228 · Kem Medical Products Corp.

Substantially Equivalent

510(k) numberK802228

Submission

Device name
Biological Indicator - Kemmed & Biosure
Applicant
Kem Medical Products Corp.
Mchenry, IL, US
Received
September 10, 1980
Decision date
December 9, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FRC – Indicator, Biological Sterilization Process
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2800
Specialty
General Hospital

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More from 3M Company

510(k)DeviceDecision
K241836Kem Medical Lead-free Chemical Indicators for Steam SterilizationJOJ · Traditional 09/30/2024SE
K181788Lead-free Chemical Indicators for Steam SterilizationJOJ · Traditional 03/01/2019SE
K802229Chemical Indicator - Kem Med & Bio SureJOJ · Traditional 12/09/1980SE

Questions and answers

When was Biological Indicator - Kemmed & Biosure cleared by the FDA?

Biological Indicator - Kemmed & Biosure (K802228) received a 510(k) decision of Substantially Equivalent on December 9, 1980, 90 days after the submission was received.

What is the product code of K802228?

The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.