510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821883Substantially Equivalent

Ultrazyme Plus Ck-I

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

K821883 is the FDA 510(k) clearance record for ULTRAZYME PLUS CK-I, a class II device, cleared for Harleco Diagnostics on under FDA product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). FDA records list 23 510(k) clearances for Harleco Diagnostics, from to . As of , FDA records show no recalls naming K821883.

Clearance record

Decision date
Received
(19 days to decision)
Product code
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
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 CGS

Trailing 12 months

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

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