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510(k) K162333

Wondfo One Step Fecal Occult Blood (FOB) Test by Guangzhou Wondfo Biotech Co., Ltd. — Product Code KHE

K162333 is an FDA 510(k) premarket notification submitted by Guangzhou Wondfo Biotech Co., Ltd. for the device "Wondfo One Step Fecal Occult Blood (FOB) Test". The FDA issued a decision of Substantially Equivalent on May 14, 2017. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Guangzhou Wondfo Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2017
Date Received
August 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

Other clearances by Guangzhou Wondfo Biotech Co., Ltd.

  • K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test (April 28, 2026)
  • K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test C (November 18, 2025)
  • K251289 — WELLlife COVID-19 Antigen Test Rx (October 22, 2025)
  • K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (September 30, 2024)
  • K241741 — SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Te (July 16, 2024)
  • K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Pan (September 25, 2020)
  • K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup (December 3, 2018)
  • K173229 — Preview Digital Pregnancy Test (March 12, 2018)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K152495 — Wondfo Propoxyphene Urine Test (November 23, 2015)

Other clearances for product code KHE

  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K170548 — InSure ONE (October 5, 2017)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K143325 — OC-Light S FIT (August 20, 2015)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)
  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (July 19, 2010)

FDA data resources