510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880803Substantially Equivalent

Wako(tm) Iga-Ha Direct

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

K880803 is the FDA 510(k) clearance record for WAKO(TM) IGA-HA DIRECT, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code CZP (Iga, 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 K880803.

Clearance record

Decision date
Received
(29 days to decision)
Product code
CZP Iga, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Wako Chemicals USA, Inc. 12300 Ford Rd., Dallas TX
Third party review
No

Clearances, product code CZP

Trailing 12 months

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

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