510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800847Substantially Equivalent

Entellan

Mcb Manufacturing Chemists, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800847 is the FDA 510(k) clearance record for ENTELLAN, a class I device, cleared for Mcb Manufacturing Chemists, Inc. on under FDA product code KEP (Media, Mounting, Oil Soluble). FDA records list 5 510(k) clearances for Mcb Manufacturing Chemists, Inc., from to . As of , FDA records show no recalls naming K800847.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KEP Media, Mounting, Oil Soluble
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Mcb Manufacturing Chemists, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEP

Trailing 12 months

FDA records hold no clearances under product code KEP in the trailing twelve months.

FDA records show no clearances under product code KEP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260