510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810475Substantially Equivalent

Helena Hemoglobin F Controls

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

K810475 is the FDA 510(k) clearance record for HELENA HEMOGLOBIN F CONTROLS, a class II device, cleared for Helena Laboratories on under FDA product code KQI (Assay, Fetal Hemoglobin). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K810475.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KQI Assay, Fetal Hemoglobin
Regulation
21 CFR 864.7455
Device class
Class II
Review panel
Hematology
Applicant
Helena Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQI

Trailing 12 months

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

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