510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861508Substantially Equivalent

Wako Micro Tp

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

K861508 is the FDA 510(k) clearance record for WAKO MICRO TP, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code CEK (Biuret (Colorimetric), Total Protein). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K861508.

Clearance record

Decision date
Received
(118 days to decision)
Product code
CEK Biuret (Colorimetric), Total Protein
Regulation
21 CFR 862.1635
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 CEK

Trailing 12 months

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

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