510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873366Substantially Equivalent

Wako(tm) Pretest 5A

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

K873366 is the FDA 510(k) clearance record for WAKO(TM) PRETEST 5A, a class I device, cleared for Wako Chemicals USA, Inc. on under FDA product code CDM (Diazonium Colorimetry, Urobilinogen (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 K873366.

Clearance record

Decision date
Received
(153 days to decision)
Product code
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Regulation
21 CFR 862.1785
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 CDM

Trailing 12 months

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

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