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, Methadone
510(k) Number K934667
Device Name METHADONE ENZYME IMMUNOASSAY
Applicant
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact YUH-GENG TSAY
Regulation Number862.3620
Classification Product Code
DJR  
Date Received09/29/1993
Decision Date 01/26/1994
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
-
-