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 K030405
Device Name QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
Applicant
Seradyn
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Applicant Contact LES PADILLA
Correspondent
Seradyn
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Correspondent Contact LES PADILLA
Regulation Number862.3645
Classification Product Code
LEG  
Subsequent Product Code
JIS  
Date Received02/06/2003
Decision Date 04/28/2003
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
-
-