510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780101Substantially Equivalent

Ultrazyme Plus Ldh

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

K780101 is the FDA 510(k) clearance record for ULTRAZYME PLUS LDH, a class II device, cleared for Harleco on under FDA product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K780101.

Clearance record

Decision date
Received
(25 days to decision)
Product code
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Regulation
21 CFR 862.1440
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 CFJ

Trailing 12 months

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

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