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 NumberK141647
Test Name Healgen MOP One Step Morphine Test Cassette  
Manufacturer NameHEALGEN SCIENTIFIC, LLC
Consumer Information Phone Number1(866)982-3818
Test TypeMorphine
Effective Date07/18/2014
Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K141647
Device Name HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
Applicant
HEALGEN SCIENTIFIC, LLC
504 EAST DIAMNOND AVE. SUITE F
GAITHERSBURG,  MD  20877
Applicant Contact Joe Shia
Correspondent
HEALGEN SCIENTIFIC, LLC
504 EAST DIAMNOND AVE. SUITE F
GAITHERSBURG,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Code
DJG  
Date Received06/19/2014
Decision Date 07/17/2014
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
-
-