• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K121987
Models W7-CU, W7-P, W8-CU, W8-P, W9-CU, W9-P
Device Name WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
Original Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
504 east diamond ave.
suite f gaithersburg,  MD  20877
Original Contact joe shia
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIS   JXM  
Date Received07/06/2012
Decision Date 08/01/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-