510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873553Substantially Equivalent

Wako(tm) Pretest 8A

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

K873553 is the FDA 510(k) clearance record for WAKO(TM) PRETEST 8A, a class I device, cleared for Wako Chemicals USA, Inc. on under FDA product code JJB (Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K873553.

Clearance record

Decision date
Received
(25 days to decision)
Product code
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Regulation
21 CFR 862.1115
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wako Chemicals USA, Inc. 12300 Ford Rd., Dallas TX
Third party review
No

Clearances, product code JJB

Trailing 12 months

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

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