510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162333Substantially Equivalent

Wondfo One Step Fecal Occult Blood (FOB) Test

Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162333 is the FDA 510(k) clearance record for Wondfo One Step Fecal Occult Blood (FOB) Test, a class II device, cleared for Guangzhou Wondfo Biotech Co., Ltd. on under FDA product code KHE (Reagent, Occult Blood). FDA records list 43 510(k) clearances for Guangzhou Wondfo Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K162333.

Clearance record

Decision date
Received
(265 days to decision)
Product code
KHE Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Guangzhou Wondfo Biotech Co., Ltd. Wondfo Scientech Park, S., Guangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHE

Trailing 12 months

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

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