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, Amphetamine
510(k) Number K973075
Device Name ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Applicant Contact JAMES W HAYNES
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Correspondent Contact JAMES W HAYNES
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received08/18/1997
Decision Date 10/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-