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 Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
510(k) Number K221658
Device Name Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Applicant
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS: H24-11
Atlanta,  GA  30329
Applicant Contact Julie Villanueva, PhD
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS: H24-11
Atlanta,  GA  30329
Correspondent Contact Julie Villanueva, PhD
Classification Product Code
PBK  
Date Received06/08/2022
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-