510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771524Substantially Equivalent

Histochemical Ferric Iron Set

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

K771524 is the FDA 510(k) clearance record for HISTOCHEMICAL FERRIC IRON SET, a class I device, cleared for Harleco on under FDA product code IAE (Hematoxylin, Iron, Weigert'S). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K771524.

Clearance record

Decision date
Received
(14 days to decision)
Product code
IAE Hematoxylin, Iron, Weigert'S
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Harleco 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IAE

Trailing 12 months

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

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