510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K803241Substantially Equivalent

Histological Embedding Media

Miles Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803241 is the FDA 510(k) clearance record for HISTOLOGICAL EMBEDDING MEDIA, a class I device, cleared for Miles Laboratories, Inc. on under FDA product code KEO (Formulations, Paraffin, All). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K803241.

Clearance record

Decision date
Received
(36 days to decision)
Product code
KEO Formulations, Paraffin, All
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Miles Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEO

Trailing 12 months

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

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