510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970985Substantially Equivalent

Wako Total Bilirubin V

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

K970985 is the FDA 510(k) clearance record for WAKO TOTAL BILIRUBIN V, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code JFM (Enzymatic Method, Bilirubin). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K970985.

Clearance record

Decision date
Received
(34 days to decision)
Product code
JFM Enzymatic Method, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Wako Chemicals USA, Inc. 1600 Bellwood Rd., Richmond VA
510(k) summary
Summary
Third party review
No

Clearances, product code JFM

Trailing 12 months

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

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