510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880828Substantially Equivalent

Wako(tm) Igm-Ha Direct

FUJIFILM Healthcare Americas Corporation, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880828 is the FDA 510(k) clearance record for WAKO(TM) IGM-HA DIRECT, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code DFT (Igm, Antigen, Antiserum, Control). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K880828.

Clearance record

Decision date
Received
(24 days to decision)
Product code
DFT Igm, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Wako Chemicals USA, Inc. 12300 Ford Rd., Dallas TX
Third party review
No

Clearances, product code DFT

Trailing 12 months

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

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