510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770803Substantially Equivalent

Hemotology Produ&ts (5 in All)

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

K770803 is the FDA 510(k) clearance record for HEMOTOLOGY PRODU&TS (5 IN ALL), a class II device, cleared for Hycel, Inc. on under FDA product code GKK (Cyanomethemoglobin). FDA records list 19 510(k) clearances for Hycel, Inc., from to . As of , FDA records show no recalls naming K770803.

Clearance record

Decision date
Received
(64 days to decision)
Product code
GKK Cyanomethemoglobin
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Hycel, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GKK

Trailing 12 months

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

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