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, Valproic Acid
510(k) Number K891581
Device Name COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
Applicant
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Applicant Contact ALEX WESOLOWSKI
Correspondent
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Correspondent Contact ALEX WESOLOWSKI
Regulation Number862.3645
Classification Product Code
LEG  
Date Received03/20/1989
Decision Date 08/15/1989
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
-
-