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 NumberK233019
Test Name Medical Distribution Group Inc., Identify Diagnostics Multi-Drug Rapid Test Panel  
Manufacturer NameHangzhou AllTest Biotech Co., Ltd.
Consumer Information Phone Number1(888)600-0431
Test TypeAmphetamines
Effective Date09/22/2025
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K233019
Device Name AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
Applicant
Hangzhou AllTest Biotech Co., Ltd.
# 550, Yinhai St. Hangzhou Economic
& Technological Development Area
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DNK   JXM   LAF   LCM   LDJ   LFG  
NFT   NFV   NFW   NFY   NGG   NGI  
NGL   NGM   PTG   PTH   QAW  
Date Received09/22/2023
Decision Date 12/13/2023
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
-
-