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

510(k) Premarket Notification
  • 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
Device Classification Name Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
510(k) Number K013410
Device Name AT HOME DRUG TEST, MODEL 9064
Applicant
Phamatech, Inc.
9530 Padgett St., #101
San Diego,  CA  92126
Applicant Contact CARL MONGIOVI
Correspondent
Phamatech, Inc.
9530 Padgett St., #101
San Diego,  CA  92126
Correspondent Contact CARL MONGIOVI
Classification Product Code
MVO  
Date Received10/15/2001
Decision Date 12/06/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-