FDA 510(k) Premarket Notification K132630: WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)

Submission Details & Decision

Normalized public record details for 510(k) notification K132630.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K132630

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)

Product Code

DJC

Decision Date

2013-09-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2013-08-22

Related Establishments / Registrations

MEDTOX DIAGNOSTICS, INC. Registration: 1050155 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
TECO DIAGNOSTICS Registration: 1832216 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
VICTORCH MEDITEK, INC. Registration: 2032364 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
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
BTNX Inc. Registration: 3003917514 View Registration
MEDTOX DIAGNOSTICS, INC. Registration: 3004175381 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
UCP BIOSCIENCES, INC. Registration: 3004987297 View Registration
NANO-DITECH CORPORATION Registration: 3005174594 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
ATLAS MEDICAL Registration: 3007126977 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
HEALGEN SCIENTIFIC LLC Registration: 3009238284 View Registration
HANGZHOU CLONGENE BIOTECH CO., LTD. Registration: 3009414546 View Registration
Randox Teoranta Registration: 3009473156 View Registration
ASSURE TECH. (HANGZHOU) CO., LTD. Registration: 3009585529 View Registration
CO-INNOVATION BIOTECH CO.,LTD. Registration: 3010220539 View Registration
Premier Biotech, LLC Registration: 3010800486 View Registration
HONG KONG MEDSOURCING LIMITED Registration: 3010852191 View Registration
ADVIN BIOTECH, INC. Registration: 3010934853 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
PREGMATE LLC Registration: 3013679502 View Registration
QuickCo, LTD Registration: 3013684380 View Registration
RANDOX LABORATORIES LIMITED Registration: 3014607865 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
CITEST DIAGNOSTICS INC. Registration: 3023296261 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
CorDx, Inc. Registration: 3031823359 View Registration
HYSEN INC Registration: 3036649420 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3043127647 View Registration
KEVA INC. Registration: 3043196750 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.