510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842986Substantially Equivalent

Refrax Mounting Medium

Anatech, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842986 is the FDA 510(k) clearance record for REFRAX MOUNTING MEDIUM, a class I device, cleared for Anatech, Ltd. on under FDA product code LEB (Mounting Media). FDA records list 14 510(k) clearances for Anatech, Ltd., from to . As of , FDA records show no recalls naming K842986.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LEB Mounting Media
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Anatech, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LEB

Trailing 12 months

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

FDA records show no clearances under product code LEB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LEB, 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