510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812081Substantially Equivalent

Wako Nefa C Test

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

K812081 is the FDA 510(k) clearance record for WAKO NEFA C TEST, a class I device, cleared for Wako Chemicals USA, Inc. on under FDA product code JLG (Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K812081.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JLG Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
Regulation
21 CFR 862.1290
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wako Chemicals USA, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JLG

Trailing 12 months

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

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