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 Antigens, All Groups, Streptococcus Spp.
510(k) Number K212623
Device Name Healgen Strep A Rapid Test Strip (Throat Swab)
Applicant
Healgen Scientific,, LLC
5213 Maple St.
Bellaire,  TX  77401
Applicant Contact Jianqiu Fang
Correspondent
LSI International, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number866.3740
Classification Product Code
GTY  
Date Received08/18/2021
Decision Date 03/16/2022
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
Predetermined Change
Control Plan Authorized		 No
-
-