FDA 510(k) Premarket Notification K121166: WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL

Submission Details & Decision

Normalized public record details for 510(k) notification K121166.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K121166

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL

Product Code

DIO

Decision Date

2012-05-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Special

Third Party Flag

Date Received

2012-04-17

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
MEDTOX DIAGNOSTICS, INC. Registration: 1050155 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
MEDICA CORP. Registration: 1220972 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
GERMAINE LABORATORIES, INC. Registration: 1649661 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
CLINICAL REFERENCE LABORATORY, INC. Registration: 1910144 View Registration
Derby supply chain solutions Registration: 2000007960 View Registration
Alere San Diego, Inc. Registration: 2020952 View Registration
Biomerica Registration: 2025099 View Registration
Alere San Diego, Inc. Registration: 2027969 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
JANT PHARMACAL CORP. Registration: 2030633 View Registration
Carolina Liquid Chemistries Corp. Registration: 2030861 View Registration
PHAMATECH INC. Registration: 2031229 View Registration
VICTORCH MEDITEK, INC. Registration: 2032364 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
ALFA SCIENTIFIC DESIGNS, INC. Registration: 2060833 View Registration
W.H.P.M., INC. Registration: 2087033 View Registration
CALBIOTECH, INC. Registration: 2090110 View Registration
PRINCETON BIOMEDITECH CORP. Registration: 2246703 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
LIN-ZHI INTERNATIONAL, INC. Registration: 3003610499 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
BTNX Inc. Registration: 3003917514 View Registration
MEDTOX DIAGNOSTICS, INC. Registration: 3004175381 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
GUANGZHOU WONDFO BIOTECH CO., LTD. Registration: 3004635103 View Registration
OMEGA LABORATORIES, INC. Registration: 3004847291 View Registration
UCP BIOSCIENCES, INC. Registration: 3004987297 View Registration
NANO-DITECH CORPORATION Registration: 3005174594 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
W.H.P.M. Bioresearch & Technology Co., Ltd. Registration: 3005345870 View Registration
ACRO BIOTECH Inc. Registration: 3005360469 View Registration
ABON BIOPHARM (HANGZHOU) CO., LTD. Registration: 3005641941 View Registration
LUMIQUICK DIAGNOSTICS, INC. Registration: 3005984081 View Registration
Confirm Biosciences LLC Registration: 3006048451 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
ATLAS MEDICAL Registration: 3007126977 View Registration
WONDFO USA CO., LTD. Registration: 3007606081 View Registration
Fourstar Group Registration: 3007838093 View Registration
CORE TECHNOLOGY CO., LTD. Registration: 3008054239 View Registration
MICRO DISTRIBUTING II, LTD. Registration: 3008416529 View Registration
ZHEJIANG ORIENT GENE BIOTECH Registration: 3008517993 View Registration
Chemtron Biotech, Inc. Registration: 3008852306 View Registration
CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. Registration: 3008987086 View Registration
MEDICAL DISPOSABLES CORP Registration: 3009212837 View Registration
HEALGEN SCIENTIFIC LLC Registration: 3009238284 View Registration
HANGZHOU CLONGENE BIOTECH CO., LTD. Registration: 3009414546 View Registration
ASSURE TECH. (HANGZHOU) CO., LTD. Registration: 3009585529 View Registration
AZER SCIENTIFIC, INC. Registration: 3009963993 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
CO-INNOVATION BIOTECH CO.,LTD. Registration: 3010220539 View Registration
Premier Biotech, LLC Registration: 3010800486 View Registration
INPECO SA Registration: 3010825766 View Registration
HONG KONG MEDSOURCING LIMITED Registration: 3010852191 View Registration
ADVIN BIOTECH, INC. Registration: 3010934853 View Registration
Microgenics Corporation Registration: 3010939897 View Registration
Hangzhou Biotest Biotech Co.,Ltd. Registration: 3011522054 View Registration
Prometheus Bio Inc. Registration: 3011559327 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3012073813 View Registration
EASY HEALTHCARE CORPORATION Registration: 3012725363 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
SAFECARE BIOTECH(HANGZHOU)CO.,LTD Registration: 3013077867 View Registration
PREGMATE LLC Registration: 3013679502 View Registration
QuickCo, LTD Registration: 3013684380 View Registration
RANDOX LABORATORIES LIMITED Registration: 3014607865 View Registration
GENABIO DIAGNOSTICS INC Registration: 3016609999 View Registration
HANGZHOU LAIHE BIOTECH CO.,LTD. Registration: 3016610313 View Registration
Guangzhou Decheng Biotechnology Co., Ltd. Registration: 3017904598 View Registration
HOME HEALTH US INCORPORATED Registration: 3021186226 View Registration
BIALEX LAB Registration: 3021841051 View Registration
CITEST DIAGNOSTICS INC. Registration: 3023296261 View Registration
GUANGZHOU WONDFO BIOTECH CO., LTD. Registration: 3023322455 View Registration
ACESO LABORATORIES INC. Registration: 3024463179 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3027519599 View Registration
ABOUND Diagnostics, Inc Registration: 3030413233 View Registration
ASSURE TECH LLC Registration: 3030648160 View Registration
INNOVATION SCIENTIFIC PTY LTD Registration: 3031697086 View Registration
CorDx, Inc. Registration: 3031823359 View Registration
HONGKONG CONLIGHT MEDICAL GROUP LIMITED Registration: 3034694973 View Registration
HYSEN INC Registration: 3036649420 View Registration
ANALYSIS OASIS GLOBAL LLC Registration: 3042271096 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3043127647 View Registration
FOURSTAR GROUP INC. Registration: 8043323 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.