510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780829Substantially Equivalent

Sysing and Hemoglobin Reagent

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

K780829 is the FDA 510(k) clearance record for SYSING AND HEMOGLOBIN REAGENT, a class II device, cleared for Harleco on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K780829.

Clearance record

Decision date
Received
(34 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
Device class
Class II
Review panel
Hematology
Applicant
Harleco 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GKR

Trailing 12 months

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

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