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
K813043Substantially Equivalent

Ultrachem Crea Item #64972

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

K813043 is the FDA 510(k) clearance record for ULTRACHEM CREA ITEM #64972, a class II device, cleared for Harleco on under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K813043.

Clearance record

Decision date
Received
(13 days to decision)
Product code
CGX Alkaline Picrate, Colorimetry, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Harleco 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CGX

Trailing 12 months
2 clearances under product code CGX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260