Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Guangzhou Wondfo Biotech Co., Ltd."
1–24 of 43
Search insights Median review: 61d Cleared: 100% Top manufacturer: Guangzhou Wondfo Biotech Co., Ltd. Lead specialty: Toxicology
Cleared Apr 28, 2026
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 109d
Cleared Nov 18, 2025
SAFElife T-Cup Multi-Drug Urine Test Cup
K252550 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 97d
Cleared Oct 22, 2025
WELLlife COVID-19 Antigen Test Rx
K251289 · QVF
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 180d
Cleared Sep 30, 2024
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
K241317 · QYT
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 143d
Cleared Jul 16, 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
K241741 · NGL
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Sep 25, 2020
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test...
K202567 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Dec 03, 2018
Wondfo T-Cup Multi-Drug Urine Test Cup
K182701 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 67d
Cleared Mar 12, 2018
Preview Digital Pregnancy Test
K173229 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 159d
Cleared May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · KHE
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d
Cleared Jun 27, 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine...
K161214 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 59d
Cleared Nov 23, 2015
Wondfo Propoxyphene Urine Test
K152495 · JXN
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 83d
Cleared Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine...
K150022 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 213d
Cleared Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
K151478 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Apr 07, 2015
CR3 Keyless Split Sample Cup Morphine - Methamphetamine
K150602 · DNK
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 28d
Cleared Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
K150179 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
K143535 · DIS
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 29d
Cleared Dec 18, 2014
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
K142609 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 93d
Cleared Aug 25, 2014
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
K142044 · LCM
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 28d
Cleared Jul 14, 2014
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
K141532 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 34d
Cleared Apr 08, 2014
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
K140089 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 84d
Cleared Feb 25, 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Jan 31, 2014
WONDFO RAPID STREP A TEST
K133343 · GTY
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 93d
Cleared Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST...
K132630 · DJC
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Jul 31, 2013
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
K131754 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 47d