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 Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K253069
Device Name Lipoprotein (a) Molarity Assay
Applicant
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92130
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92130
Correspondent Contact Abhijit Datta
Regulation Number866.5600
Classification Product Code
DFC  
Date Received09/23/2025
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-