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


New Search Back To Search Results
Device Classification Name saline, vascular access flush
510(K) Number K121231
Device Name IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
Applicant
IND NDIAGNOSTIC INC.
1629 fosters way
delta, british columbia, 
Contact kai lou
Regulation Number880.5200
Classification Product Code
NGT  
Subsequent Product Codes
NFW   NFY   NGG   NGI  
Date Received04/24/2012
Decision Date 07/30/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee General Hospital
Review Advisory Committee Toxicology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-