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 Levetiracetam Assay
510(k) Number K232522
Device Name ARK Levetiracetam II Assay
Applicant
ARK Diagnostics, Inc.
48089 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact Dionne Labatore
Correspondent
ARK Diagnostics, Inc.
48089 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact Dionne Labatore
Regulation Number862.3350
Classification Product Code
ORI  
Date Received08/18/2023
Decision Date 02/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-