510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812594Substantially Equivalent

Ultra Zyme Plus Amyl #64982 & 65031

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

K812594 is the FDA 510(k) clearance record for ULTRA ZYME PLUS AMYL #64982 & 65031, a class II device, cleared for Harleco on under FDA product code CIJ (Saccharogenic, Amylase). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K812594.

Clearance record

Decision date
Received
(21 days to decision)
Product code
CIJ Saccharogenic, Amylase
Regulation
21 CFR 862.1070
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 CIJ

Trailing 12 months

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

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