Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangzhou Wondfo Biotech Co., Ltd. · Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
213 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip M | Guangzhou Wondfo Biotech Co., Ltd. | 2026-04-28 | 109 | 0 |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Mul | Guangzhou Wondfo Biotech Co., Ltd. | 2025-11-18 | 97 | 0 |
| K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | 2025-10-22 | 180 | 0 |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-09-30 | 143 | 0 |
| K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fen | Guangzhou Wondfo Biotech Co., Ltd. | 2024-07-16 | 29 | 0 |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi | Guangzhou Wondfo Biotech Co., Ltd. | 2020-09-25 | 21 | 0 |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018-12-03 | 67 | 1 |
| K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2018-03-12 | 159 | 0 |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 | 265 | 0 |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo | Guangzhou Wondfo Biotech Co., Ltd. | 2016-06-27 | 59 | 0 |
| K152495 | Wondfo Propoxyphene Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2015-11-23 | 83 | 0 |
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One S | Guangzhou Wondfo Biotech Co., Ltd. | 2015-08-07 | 213 | 0 |
| K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015-07-01 | 29 | 0 |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2015-04-07 | 28 | 0 |
| K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | Guangzhou Wondfo Biotech Co., Ltd. | 2015-02-25 | 29 | 0 |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | Guangzhou Wondfo Biotech Co., Ltd. | 2015-01-13 | 29 | 0 |
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | 2014-12-18 | 93 | 0 |
| K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYM | Guangzhou Wondfo Biotech Co., Ltd. | 2014-08-25 | 28 | 0 |
| K141532 | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE | Guangzhou Wondfo Biotech Co., Ltd. | 2014-07-14 | 34 | 0 |
| K140089 | CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-04-08 | 84 | 0 |
| K133968 | WONDFO MULTI-DRUG URINE TEST CUP, PANEL | Guangzhou Wondfo Biotech Co., Ltd. | 2014-02-25 | 61 | 1 |
| K133343 | WONDFO RAPID STREP A TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2014-01-31 | 93 | 0 |
| K132630 | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAM | Guangzhou Wondfo Biotech Co., Ltd. | 2013-09-27 | 36 | 0 |
| K131754 | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URI | Guangzhou Wondfo Biotech Co., Ltd. | 2013-07-31 | 47 | 0 |
| K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URIN | Guangzhou Wondfo Biotech Co., Ltd. | 2013-05-31 | 30 | 0 |
| K130665 | WONDOFO MULTI-DRUG URINE TEST CUP / PANEL | Guangzhou Wondfo Biotech Co., Ltd. | 2013-04-09 | 28 | 0 |
| K130055 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP | Guangzhou Wondfo Biotech Co., Ltd. | 2013-02-14 | 36 | 0 |
| K122961 | WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAM | Guangzhou Wondfo Biotech Co., Ltd. | 2012-12-21 | 87 | 0 |
| K122904 | WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W | Guangzhou Wondfo Biotech Co., Ltd. | 2012-11-15 | 55 | 0 |
| K121987 | WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2012-08-01 | 26 | 0 |
| K121557 | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TES | Guangzhou Wondfo Biotech Co., Ltd. | 2012-07-25 | 61 | 0 |
| K121166 | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TES | Guangzhou Wondfo Biotech Co., Ltd. | 2012-05-08 | 21 | 0 |
| K113624 | WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2012-03-12 | 95 | 0 |
| K112071 | WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAM | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-23 | 65 | 0 |
| K112236 | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORP | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-19 | 46 | 0 |
| K112395 | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS U | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-09 | 21 | 0 |
| K112310 | WONDFO METHADONE URINE TEST,OPIATE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-08 | 29 | 0 |
| K111560 | WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TES | Guangzhou Wondfo Biotech Co., Ltd. | 2011-07-15 | 42 | 0 |
| K110182 | CANNABINOIDS URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2011-05-20 | 119 | 0 |
| K093175 | WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TE | Guangzhou Wondfo Biotech Co., Ltd. | 2010-08-25 | 321 | 0 |
| K072500 | ONE STEP HCG URINE/SERUM TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 | 594 | 0 |
| K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | Guangzhou Wondfo Biotech Co., Ltd. | 2005-11-17 | 316 | 0 |
| K043443 | ONE STEP HCG URINE PREGNANCY TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2005-04-08 | 115 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda