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 NumberK142280
Test Name Virginia Kendall Corporation, Budpak Morphine Test Strip  
Manufacturer NameHEALGEN SCIENTIFIC LLC
Consumer Information Phone Number1(301)696-8879
Test TypeMorphine
Effective Date12/07/2017
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K142280
Device Name Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
Applicant
HEALGEN SCIENTIFIC LLC
5213 MAPLE STREET
BELLAIRE,  TX  77401
Applicant Contact Jianqiu Fang
Correspondent
LSI INTERNATIONAL INC.
504 EAST DIAMOND AVE. SUITE I
GAITHERSBURG,  MD  20877
Correspondent Contact Joe Xia
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
JXM  
Date Received08/15/2014
Decision Date 10/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-