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 Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K041441
Device Name SAS INFLUENZA A TEST
Applicant
SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO,  TX  78240
Applicant Contact RICARDO R MARTINEZ
Correspondent
SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO,  TX  78240
Correspondent Contact RICARDO R MARTINEZ
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received06/01/2004
Decision Date 07/22/2004
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
-
-