510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780103Substantially Equivalent

Ultrazyme Plus Got

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

K780103 is the FDA 510(k) clearance record for ULTRAZYME PLUS GOT, a class II device, cleared for Harleco on under FDA product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K780103.

Clearance record

Decision date
Received
(24 days to decision)
Product code
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Regulation
21 CFR 862.1100
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 CIT

Trailing 12 months

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

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