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 Anti-Müllerian Hormone Test System
510(k) Number K221801
Device Name ADVIA Centaur® Anti-Müllerian Hormone (AMH)
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Mey Vasquez
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Mey Vasquez
Classification Product Code
PQO  
Subsequent Product Code
JJX  
Date Received06/21/2022
Decision Date 06/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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
-
-