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 antisera, neutralization, influenza virus a, b, c
510(k) Number K984596
Device Name VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
Applicant
ZYMETX, INC.
800 RESEARCH PKWY., SUITE 100
OKLAHOMA CITY,  OK  73104
Applicant Contact CRAIG D SHIMASAKI
Correspondent
ZYMETX, INC.
800 RESEARCH PKWY., SUITE 100
OKLAHOMA CITY,  OK  73104
Correspondent Contact CRAIG D SHIMASAKI
Regulation Number866.3330
Classification Product Code
GNR  
Date Received12/28/1998
Decision Date 03/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-