• 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 NumberK153646
Test Name Safecare Biotech (Hangzhou) Co., Ltd., FIRSTVIEW Urine Test Amphetamine Cassette  
Manufacturer NameSAFECARE BIOTECH (HANGZHOU)CO.,LTD.
Consumer Information Phone Number1(202)330-1900
Test TypeAmphetamines
Effective Date07/11/2023
Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K153646
Device Name SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
Applicant
SAFECARE BIOTECH (HANGZHOU)CO.,LTD.
BUILDING 2/203 NO.18 HAISHU RD.,
CANGQIAN SUB-DISTRICT, YUHANG DISTRICT
HANGZHOU,  CN 311121
Applicant Contact Alex Qiu
Correspondent
LSI INTERNATIONAL
504 E DIAMOND AVE
SUITE.I
GAITHERSBURG,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DKZ   LDJ  
Date Received12/21/2015
Decision Date 03/18/2016
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
-
-