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 Enzyme Immunoassay, Opiates
510(k) Number K943248
Device Name VISUALINE II MORPHINE/OPIATES/HEROIN
Applicant
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Applicant Contact MING SUN
Correspondent
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Correspondent Contact MING SUN
Regulation Number862.3650
Classification Product Code
DJG  
Date Received07/06/1994
Decision Date 01/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-