510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821869Substantially Equivalent

Ultrazyme Plus Amyl

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

K821869 is the FDA 510(k) clearance record for ULTRAZYME PLUS AMYL, a class II device, cleared for Harleco Diagnostics on under FDA product code JFJ (Catalytic Methods, Amylase). FDA records list 23 510(k) clearances for Harleco Diagnostics, from to . As of , FDA records show no recalls naming K821869.

Clearance record

Decision date
Received
(18 days to decision)
Product code
JFJ Catalytic Methods, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Harleco Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JFJ

Trailing 12 months

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

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