Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back to Search Results
Document NumberK152495
Test Name Jant Pharmacal Corporation Accutest Propoxyphene Urine Test Cup  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(818)986-8530
Test TypePropoxyphene
Effective Date12/22/2016
Device Classification Name Enzyme Immunoassay, Propoxyphene
510(k) Number K152495
Device Name Wondfo Propoxyphene Urine Test
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
Wondfo Scientech Park, S.
China Univ. Of Technology
Guangzhou,  CN 510641
Applicant Contact Ben Chen
Correspondent
LSI International, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3700
Classification Product Code
JXN  
Date Received09/01/2015
Decision Date 11/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-