510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880313Substantially Equivalent

Wako(tm) Autokit Albumin

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

K880313 is the FDA 510(k) clearance record for WAKO(TM) AUTOKIT ALBUMIN, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code CIX (Bromcresol Green Dye-Binding, Albumin). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K880313.

Clearance record

Decision date
Received
(59 days to decision)
Product code
CIX Bromcresol Green Dye-Binding, Albumin
Regulation
21 CFR 862.1035
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Wako Chemicals USA, Inc. 12300 Ford Rd., Dallas TX
Third party review
No

Clearances, product code CIX

Trailing 12 months
1 clearance under product code CIX in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260