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
K812591Substantially Equivalent

Ultra Zyme Plus Gpt, #64956, 65035 & 36

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

K812591 is the FDA 510(k) clearance record for ULTRA ZYME PLUS GPT, #64956, 65035 & 36, a class I device, cleared for Harleco on under FDA product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K812591.

Clearance record

Decision date
Received
(13 days to decision)
Product code
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Regulation
21 CFR 862.1030
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 CKA

Trailing 12 months

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

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