510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812558Substantially Equivalent

Tissue-Tek III Accu-Cut Rotary Microtome

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

K812558 is the FDA 510(k) clearance record for TISSUE-TEK III ACCU-CUT ROTARY MICROTOME, a class I device, cleared for Miles Laboratories, Inc. on under FDA product code IDO (Microtome, Rotary). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K812558.

Clearance record

Decision date
Received
(21 days to decision)
Product code
IDO Microtome, Rotary
Regulation
21 CFR 864.3010
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 IDO

Trailing 12 months

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

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