Acrytol, Mounting Medium

FDA 510(k) K810323 · Surgipath

Substantially Equivalent

510(k) numberK810323

Submission

Device name
Acrytol, Mounting Medium
Applicant
Surgipath
Mchenry, IL, US
Received
February 6, 1981
Decision date
March 6, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KEP – Media, Mounting, Oil Soluble
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code KEP

510(k)DeviceApplicantDecision
K830659Clearium, Mounting MediumKEP · Traditional Surgipath Medical Industries, Inc.03/17/1983SE
K800847EntellanKEP · Traditional Mcb Manufacturing Chemists, Inc.05/08/1980SE

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K811825Orange G-6HZH · Traditional 07/10/1981SE
K810836Decalcifier IIKDX · Traditional 04/23/1981SE
K810760Gill's Hematoxylin #3 · Traditional 04/14/1981SE
K810759Gill's Hematoxylin #2HYJ · Traditional 04/14/1981SE
K810758Gill's Hematoxylin #1HYJ · Traditional 04/14/1981SE

Questions and answers

When was Acrytol, Mounting Medium cleared by the FDA?

Acrytol, Mounting Medium (K810323) received a 510(k) decision of Substantially Equivalent on March 6, 1981, 28 days after the submission was received.

What is the product code of K810323?

The FDA product code is KEP – Media, Mounting, Oil Soluble, a Class I (low risk) device regulated under 21 CFR 864.4010.