510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813413Substantially Equivalent

Lectin H

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

K813413 is the FDA 510(k) clearance record for LECTIN H, a class II device, cleared for American Dade on under FDA product code KSI (Lectins And Protectins). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K813413.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KSI Lectins And Protectins
Regulation
21 CFR 864.9550
Device class
Class II
Review panel
Hematology
Applicant
American Dade 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSI

Trailing 12 months

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

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