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
K780523Substantially Equivalent

Ultrachem Enzymatic Cholesterol 65025

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

K780523 is the FDA 510(k) clearance record for ULTRACHEM ENZYMATIC CHOLESTEROL 65025, a class I device, cleared for Harleco on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K780523.

Clearance record

Decision date
Received
(49 days to decision)
Product code
CHH Enzymatic Esterase--Oxidase, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Harleco 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CHH

Trailing 12 months
1 clearance under product code CHH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260