510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K870095Substantially Equivalent

Bilirubin Tester

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

K870095 is the FDA 510(k) clearance record for BILIRUBIN TESTER, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K870095.

Clearance record

Decision date
Received
(145 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
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 CIG

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