Entellan

FDA 510(k) K800847 · Mcb Manufacturing Chemists, Inc.

Substantially Equivalent

510(k) numberK800847

Submission

Device name
Entellan
Applicant
Mcb Manufacturing Chemists, Inc.
Mchenry, IL, US
Received
April 15, 1980
Decision date
May 8, 1980
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
K810323Acrytol, Mounting MediumKEP · Traditional Surgipath03/06/1981SE

More from Surgipath

510(k)DeviceDecision
K801212Wrights Rapid StainIAF · Traditional 05/30/1980SE
K792026Wrights Rapid StainIAF · Traditional 11/13/1979SE
K791929Wrights Rapid StainIAF · Traditional 10/11/1979SE
K782066ExetrelutKEA · Traditional 01/03/1979SE

Questions and answers

When was Entellan cleared by the FDA?

Entellan (K800847) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 23 days after the submission was received.

What is the product code of K800847?

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