• 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

IVD Over the Counter (OTC) record K170049 and corresponding
510(K) Premarket Notification information

Test NameAssure Tech. Co., Ltd. AssureTech Panel Dip Tests  
Manufacturer NameASSURE TECH (HANGZHOU) CO., LTD.
Consumer Information Phone Number(510)860-4680
IVD Document NumberK170049
Test TypeBenzodiazepines
Effective Date07/28/2017
Device Classification Name test, amphetamine, over the counter
510(k) Number K170049
Device Name AssureTech Panel Dip Test, AssureTech Quick Cup Test
Applicant
ASSURE TECH (HANGZHOU) CO., LTD.
NO.10, XIYUANSAN RD.
WESTLAKE ECONOMIC ZONE
hangzhou,  CN 310030
Applicant Contact shisheng ling
Correspondent
LSI INTERNATIONAL
504 E DIAMOND AVE.
SUITE I
gaithersburg,  MD  20877
Correspondent Contact joe shia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
NFV   NFW   NFY   NGG   NGL  
NGM   PTG   PTH  
Date Received01/05/2017
Decision Date 05/02/2017
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
-
-