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 K030447
Device Name AT HOME DRUG CUP, MODEL 9150X
Applicant
Phamatech
9530 Padgett St., #101
San Diego,  CA  92126
Applicant Contact CARL MONGIOVI
Correspondent
Phamatech
9530 Padgett St., #101
San Diego,  CA  92126
Correspondent Contact CARL MONGIOVI
Classification Product Code
MVO  
Subsequent Product Codes
DIO   DJG   DKZ   LAF   LDJ  
Date Received02/11/2003
Decision Date 04/14/2003
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
-
-